NRAC Issue #1893

May 22, 2012

14 Pages

NATIONAL RECALL ALERT CENTER - IMMEDIATE WARNING ALERT NOTIFICATION

THE FOLLOWING HAVE BEEN RECALLED OR ARE SUBJECT TO FIELD CORRECTION
THIS LISTING IS ISSUED BY - NATIONAL RECALL ALERT CENTER, WASHINGTON, D.C.

SUMMARY PAGE
MEDICAL DEVICES
PRODUCT
ABL80FLEX Blood Gas, pH, Electrolyte & Metabolite system
MANUFACTURER
SenDx Medical Inc
PAGE 11
PRODUCT
Coloplast, Restorelle DirectFix, Posterior Polypropylene mesh
MANUFACTURER
Coloplast A/S, Culzean Medical Devices, Ltd
PAGE 12
PRODUCT
Crystal Metal Disposable blades
MANUFACTURER
Penlon, Ltd
PAGE 10
PRODUCT
Curlin IV administration sets (update to NRAC Issue #1889)
MANUFACTUER
Moog Medical Devices Group
PAGE 4
PRODUCT
DeRoyal Episeal sterile & non-sterile wound closure strips and kits
MANUFACTURER
DeRoyal Industries, Inc
PAGE 5
PRODUCT
Dimension Vista Total Prostate Specific Antigen Flex reagent cartridge
MANUFACTURER
Siemens Healthcare Diagnostics, Inc
PAGE 11
PRODUCT
Evolution steam sterilizers
MANUFACTURER
Steris Mexico
PAGE 12
PRODUCT
Fresenius Liberty Cycler software, user manuals & Handi-Guides
MANUFACTURER
Fresenius USA, Inc
PAGE 12
PRODUCT
Galil Medical 17G Cryoablation needle holder
MANUFACTURER
Galil Medical Ltd
PAGE 13
PRODUCT
Philips Digital Diagnost Systems with Eleva software
MANUFACTURER
Philips Medical systems GmbH
PAGE 10
PRODUCT
Siemens ONCOR or PRIMUS linear accelerator with OPTIVUE or MVision
MANUFACTURER
Siemens Ag Medical Solutions
PAGE 12
PRODUCT

S.M.A.R.T. Transhepatic & Control Transhepatic Biliary stent

MANUFACTURER
PAGE 11

Cordis de Mexico

PRODUCT
TrueBeam
MANUFACTURER
Varian Medical Systems Inc, Oncology Systems
PAGE 10
PRODUCT
Vacuum Tissue processor
MANUFACTURER
Leica Biosystems Nussloch GmbH
PAGE 13
BIOLOGICALS
PRODUCT
Pneumococcal 13-valent conjugate vaccine
MANUFACTURER
Pfizer, Inc
PAGE 13
PHARMACEUTICALS
PRODUCT
Celestone brand betamethasone oral solution
MANUFACTURER
Merck, Inc
PAGE 14
PRODUCT
Excelsior Disposable Syringe Heparin Lock Flush
MANUFACTURER
Excelsior Medical
PAGE 2
-----------------------------------------------------------------------------------------------------------------------------------------------PRODUCT
RECALL NUMBER
CODE

Excelsior Disposable Syringe Heparin Lock Flush, USP, 3 mL fill in 10mL syringe, 4mL fill
in 10 mL syringe, 5 mL fill in 10 mL syringe, 6 mL fill in 10 mL syringe
Not available at publication
Item code: Lot #, Exp date:
513602: 87-010-BN, 3/1/13; 99-010-BN, 3/1/14
513604: 85-001-BN, 5/1/13; 85-002-BN, 5/1/13; 85-004-BN, 5/1/13; 85-012-BN, 5/1/13;
90-004-BN, 6/1/13; 90-005-BN, 6/1/13; 90-011-BN, 6/1/13; 90-012-BN, 6/1/13; 91-004BN, 7/1/13; 92-002-BN, 8/1/13; 92-003-BN, 8/1/13; 92-004-BN, 8/1/13; 92-001-BN,
8/1/13; 92-012-BN, 8/1/13; 95-005-BN, 11/1/13; 96-006-BN, 11/1/13; 95-010-BN, 11/1/13;
95-015-BN, 11/1/13; 95-016-BN, 11/1/13; 96-002-BN. 12/1/13; 96-004-BN, 12/1/13; 96005-BN, 12/1/13; 97-008-BN, 1/1/14; 97-009-BN, 1/1/14; 97-010-BN, 1/1/14; 97-011-BN,
1/1/14; 97-015-BN, 1/1/14; 97-017-BN, 1/1/14; 97-021-BN, 1/1/14; 98-016-BN, 2/1/14; 99002-BN, 3/1/14; 99-006-BN, 3/1/14; 99-007-BN, 3/1/14; 99-011-BN, 3/1/14
30031-240: 92-056-9D, 8/1/12; 01-031-9D, 5/1/13; 92-057-9D, 8/1/12; 92-155-9D, 8/1/12
44031-240: 01-043-9D, 5/1/13; 01-065-9D, 5/1/13; 90-058-9D, 6/1/12
50031-1000: 03-115-9D, 7/1/13; 97-123-9D, 1/1/13
50031-240: 00-114-9D, 4/1/13
50051-1000: 01-002-9D, 5/1/13; 02-095-9D, 6/1/13; 04-024-9D, 8/1/13;04-111-9D, 8/1/13;
08-004-9D, 12/1/13; 09-015-9D, 1/1/14; 09-060-9D, 1/1/14; 09-081-9D, 1/1/14; 12-008-9D,
4/1/14; 91-053-9D, 7/1/12; 91-136-9D, 7/1/12; 92-109-9D, 8/1/12; 93-077-9D, 9/1/12; 97052-9D, 1/1/13; 98-026-9D, 2/1/13; 99-027-9D, 3/1/13; 99-102-9D, 3/1/13
50051-240: 01-009-9D, 5/1/13; 03-110-9D, 7/1/13; 05-068-9D, 9/1/13; 08-009-9D, 12/1/13;
09-014-9D, 1/1/14; 09-061-9D, 1/1/14; 90-049-9D, 6/1/12; 92-108-9D, 8/1/12; 93-065-9D,
9/1/12; 93-065-9D, 9/1/12; 93-067-9D, 9/1/12; 99-103-9D, 3/1/13; 99-143-9D, 3/1/13; 01008-9D, 5/1/13; 01-050-9D, 5/1/13; 01-050-9D, 5/1/13; 04-025-9D, 8/1/13; 05-078-9D,
9/1/13; 07-025-9D, 11/1/13; 08-005-9D, 12/1/13; 09-063-9D, 1/1/14; 11-009-9D, 3/1/14;
91-052-9D, 7/1/12; 91-084-9D, 7/1/12; 92-111-9D, 8/1/12; 98-025-9D, 2/1/13; 99-035-9D,

3/1/13; 00-015-9D, 4/1/13

56031-240: 00-015-9D, 4/1/13; 00-115-9D, 4/1/13; 03-012-9D, 7/1/13; 03-113-9D, 7/1/13;
03-116-9D, 7/1/13; 08-067-9D, 12/1/13; 08-071-9D, 12/1/13; 08-073-9D, 12/1/13; 93-0889D, 9/1/12; 97-066-9D, 1/1/13
56051-240: 90-048-9D, 6/1/12; 91-058-9D, 7/1/12; 91-059-9D, 7/1/12; 91-135-9D, 7/1/12;
92-110-9D, 8/1/12; 93-062-9D, 9/1/12; 93-063-9D, 9/1/12; 97-051-9D, 1/1/13; 97-053-9D,
1/1/13; 97-071-9D, 1/1/13; 97-083-9D, 1/1/13
60031-1000: 08-061-9D, 12/1/13; 10-008-9D, 2/1/14; 10-015-9D, 2/1/14; 10-025-9D,
2/1/14; 91-050-9D, 7/1/12; 92-078-90D, 8/1/12; 98-107-9D, 2/1/13; 98-137-9D, 2/1/13;
60031-240: 01-034-9D, 5/1/13; 03-024-9D, 7/1/13; 03-083-9D, 7/1/13; 03-112-9D, 7/1/13;
07-045-9D, 11/1/13; 08-062-9D, 12/1/13; 10-009-9D, 2/1/14; 10-026-9D, 2/1/14; 91-0379D, 7/1/12; 92-077-9D, 8/1/12; 92-102-9D, 8/1/12; 98-106-9D, 2/1/13; 99-129-9D, 3/1/13;
99-147-9D, 4/1/13
60051-1000: 00-013-9D, 4/1/13; 00-108-9D, 4/1/13; 02-079-9D, 6/1/13; 02-099-9D,
6/1/13;03-092-9D, 7/1/13; 04-060-9D, 8/1/13; 04-089-9D, 8/1/13; 04-139-9D, 8/1/13; 06074-9D, 10/1/13; 06-076-9D, 10/1/13; 07-022-9D, 11/1/13; 07-052-9D, 11/1/13; 07-054-9D,
11/1/13; 07-054-9D, 11/1/13; 08-033-9D, 12/1/13; 08-036-9D, 12/1/13; 08-068-9D,
12/1/13; 09-011-9D, 1/1/14; 09-027-9D, 1/1/14; 09-040-9D, 1/1/14; 09-071-9D, 1/1/14; 90141-9D, 6/1/12; 90-150-9D, 6/1/12; 91-025-9D, 7/1/12; 97-030-9D, 1/1/13; 97-031-9D,
1/1/13; 97-111-9D, 1/1/13; 98-128-9D, 2/1/13; 99-024-9D, 3/1/13; 99-068-9D, 3/1/13; 99140-9D, 3/1/13
60051-240: 00-008-9D, 4/1/13; 00-011-9D, 4/1/13; 00-101-9D, 4/1/13; 02-069-9D, 6/1/13;
04-023-9D, 8/1/13; 04-092-9D, 8/1/13; 04-130-9D, 8/1/13; 07-027-9D, 11/1/13; 07-042-9D,
11/1/13; 08-021-9D, 12/1/13; 09-039-9D, 1/1/14; 90-132-9D 6/1/12; 90-140-9D, 6/1/12; 96059-9D, 12/1/12; 97-006-9D, 1/1/13; 97-015-9D, 1/1/13; 97-016-9D, 1/1/13; 98-095-9D,
2/1/13; 98-127-9D, 2/1/13; 99-059-9D, 3/1/13
64051-240: 01-035-9D, 5/1/13; 02-068-9D, 6/1/13; 04-027-9D, 8/1/13; 07-021-9D, 11/1/13
11-017-9D, 3/1/14; 90-127-9D, 6/1/12; 92-043-9D, 8/1/12; 96-094-9D, 12/1/12; 96-095-9D,
12/1/12; 97-110-9D, 1/1/13; 98-071-9D, 1/1/13; 99-078-9D, 3/1/13
66031-240: 01-005-9D, 5/1/13; 01-062-9D, 5/1/13; 01-063-9D, 5/1/13; 03-082-9D, 7/1/13;
07-046-9D, 11/1/13; 08-060-9D, 12/1/13; 10-010-9D, 2/1/14; 91-036-9D, 7/1/12; 92-0799D, 8/1/12; 97-040-9D, 1/1/13; 99-130-9D, 3/1/13
66051-240: 00-012-9D, 4/1/13; 01-036-9D, 5/1/13; 01-055-9D, 5/1/13; 02-065-9D, 6/1/13;
02-067-9D, 6/1/13; 02-100-9D, 6/1/13; 07-020-9D, 11/1/13; 07-031-9D, 11/1/13; 07-0339D, 11/1/13; 07-033-9D, 11/1/13; 07-041-9D, 11/1/13; 08-037-9D, 12/1/13; 08-048-9D,
12/1/13; 09-007-9D, 1/1/14; 09-009-9D, 1/1/14; 09-022-9D, 1/1/14; 10-001-9D, 2/1/14; 10012-9D, 2/1/14; 90-034-9D, 6/1/12; 90-093-9D, 6/1/12; 90-109-9D, 6/1/12; 91-015-9D,
7/1/12; 92-044-9D, 8/1/12; 92-070-9D, 8/1/12; 92-072-9D, 8/1/12; 92-073-9D, 8/1/12; 96050-9D, 12/1/12; 96-096-9D, 12/1/12; 96-097-9D, 12/1/12; 97-017-9D, 1/1/13; 97-095-9D,
1/1/13; 98-010-9D, 2/1/13; 98-018-9D, 2/1/13; 98-074-9D, 2/1/13; 99-041-9D, 3/1/13; 99043-9D, 3/1/13; 99-079-9D, 3/1/13; 99-088-9D, 3/1/13
860051-240: 00-079-9D, 4/1/13
870031-240: 01-057-9D, 5/1/13; 03-032-9D, 7/1/13; 10-018-9D, 2/1/14; 91-078-9D, 7/1/12;
98-041-9D, 2/1/13; 98-075-9D, 2/1/13; 98-139-9D, 2/1/13
870041-240: 00-030-9D, 4/1/13; 03-073-9D, 7/1/13; 97-044-9D, 1/1/13; 98-033-9D, 2/1/13;
870051-240: 02-041-9D, 6/1/13; 02-052-9D, 6/1/13; 10-017-9D, 2/1/14; 97-047-9D, 1/1/13;
98-068-9D, 2/1/13
870061-240: 00-022-9D, 4/1/13; 01-054-9D, 5/1/13; 03-067-9D, 7/1/13; 08-041-9D,
12/1/13; 90-067-9D, 6/1/12; 90-068-9D, 6/1/12; 91-137-9D, 7/1/12; 99-055-9D, 3/1/13
950031-1000: 93-087-9D, 9/1/12; 93-066-9D, 9/1/12; 97-094-9D, 1/1/13
E0300-35: 01-012-9D, 5/1/9D, 5/1/13; 01-030-9D, 5/1/13; 03-081-9D, 7/1/13; 03-111-9D,
7/1/13; 03-114-9D, 7/1/13; 08-043-9D, 12/1/13; 08-069-9D, 12/1/13; 08-070-9D, 12/1/13;
08-072-9D, 12/1/13; 11-047-9D, 3/1/14; 91-103-9D, 7/1/12; 92-055-9D, 8/1/12; 92-058-9D,
8/1/12; 92-154-9D, 8/1/12; 95-040-9D, 11/1/12; 97-062-9D, 1/1/13; 97-112-9D, 1/1/13; 99008-9D, 3/1/13; 99-146-9D, 3/1/13
E0400-35: 01-042-9D, 5/1/13; 01-064-9D, 5/1/13; 01-066-9D, 5/1/13; 90-057-9D, 6/1/12;

90-192-9D, 6/1/12
E0500-55: 01-003-9D, 5/1/13; 01-017-9D, 5/1/13; 01-049-9D, 5/1/13; 02-094-9D, 6/1/13;
04-013-9D, 8/1/13; 05-076-9D, 9/1/13; 05-079-9D, 9/1/13; 07-024-9D, 11/1/13; 07-063-9D,
11/1/13; 08-001-9D, 12/1/13; 08-042-9D, 12/1/13; 09-016-9D, 1/1/14;92-107-9D, 8/1/12;
93-064-9D, 9/1/12; 96-065-9D, 12/1/12; 97-048-9D, 1/1/13; 98-014-9D, 2/1/13; 98-024-9D,
2/1/13; 99-073-9D, 3/1/13; 99-104-9D, 3/1/13; 99-113-9D, 3/1/13; 99-144-9D, 3/1/13
E0600-55: 00-093-9D, 4/1/13; 00-105-9D, 4/1/13; 01-016-9D, 5/1/13; 01-028-9D, 5/1/13;
01-028-9D, 5/1/13; 02-004-9D, 6/1/13; 02-053-9D, 6/1/13; 02-060-9D, 6/1/13; 03-108-9D,
7/1/13; 04-028-9D, 8/1/13; 04-046-9D, 8/1/13; 04-072-9D, 8/1/13; 04-099-9D, 8/1/13; 04123-9D, 8/1/13; 06-073-9D, 10/1/13; 06-075-9D, 10/1/13; 07-019-9D, 11/1/13; 07-023-9D,
11/1/13; 07-028-9D, 11/1/13; 07-049-9D, 11/1/13; 07-053-9D, 11/1/13; 08-017-9D,
12/1/13; 08-032-9D, 12/1/13; 08-034-9D, 12/1/13; 08-064-9D, 12/1/13; 09-031-9D, 1/1/14;
09-041-9D, 1/1/14; 09-053-9D, 1/1/14; 10-014-9D, 2/1/14; 10-055-9D, 2/1/14; 90-019-9D,
6/1/12; 90-151-9D, 6/1/12; 90-169-9D, 6/1/12; 90-170-9D, 6/1/12; 91-005-9D, 7/1/12; 91049-9D, 7/1/12; 92-003-9D, 8/1/12; 92-015-9D, 8/1/12; 92-095-9D, 8/1/12; 92-123-9D,
8/1/12; 96-082-9D, 12/1/12; 97-024-9D, 1/1/13; 97-029-9D, 1/1/13; 97-097-9D, 1/1/13; 97105-9D, 1/1/13; 98-004-9D, 2/1/13; 98-069-9D, 2/1/13; 98-081-9D, 2/1/13; 99-032-9D,
3/1/13; 99-034-9D, 3/1/13; 99-118-9D, 3/1/13; 99-135-9D, 3/1/13
PS100U: 04-044-9D, 8/1/13; 04-045-9D, 8/1/13; 07-038-9D, 11/1/13; 07-039-9D, 11/1/13;
07-040-9D, 11/1/13; 09-077-9D, 1/1/14; 09-078-9D, 1/1/14; 90-110-9D, 6/1/12; 90-126-9D,
6/1/12; 91-139-9D, 7/1/12; 92-002-9D, 8/1/12
MANUFACTURED & RECALLED BY
Excelsior Medical, Neptune, NJ
QUANTITY
Not available at publication
DISTRIBUTION
Nationwide
REASON
Some lots failed the Anti-Factor IIa assay for potency. Based on the results of this internal
testing and because these syringes do not meet the USP monograph requirement for potency,
Excelsior is recalling all syringes contained in these lots.
CONTACT
Customer Service at 800-487-4276
-----------------------------------------------------------------------------------------------------------------------------------------------The following is an update to NRAC Issue #1889 dated 4/24/12
PRODUCT

Curlin Intravenous Administration sets, Reference numbers 340-4173 and 340-4168 are
being added to the affected products
RECALL NUMBER
Not available at publication
CODE
The following are additional codes: CF1127990, CF1127991, CF1127992, CF1129990,
CF1130190, CF1130690, CF1130691, CF1130693, CF1131190, CF1131191, CF1130692,
CF1132290, CF1132291, CF1133491, CF1134390, CF1134391, CF1133490, CF1134392,
CF1134990, CF1134393, CF1135490, CF1135491, CF1135492, CF1200290, CF1200291,
CF1200292, CF1200490, CF1200491, CF1200492, CF1200493, CF1200293, CF1200494,
CF1200294, CF1201893, CF1201890, CF1201190, CF1201192, CF1202591, CF1202590,
CF1201891, CF1201191, CF1201892, CF1202592, CF1204092, CF1204093, CF1203391,
CF1204091, CF1203392, CF1203390, CF1204090, CF1204690, CF1204691, CF1205491,
CF1204692, CF1205490, CF1205990, CF1205492, CF1206890, CF1206891, CF1205493,
CF1206090,CF1206091, CF1206092, CF1208090, CF1206893, CF1207592, CF1207590,
CF1207591, CF1207593, CF1209091, CF1308091, CF1208092
MANUFACTURED & RECALL BY
Moog Medical Devices Group, Salt Lake City, UT
QUANTITY
Not available at publication
DISTRIBUTION
Nationwide
REASON
The recall was initiated as a result of the discovery of a reverse pump segment by customers
and reported to Moog. To date, Customer complaints have identified (3) three out of
544,900 suspect sets manufactured for the United States. Use of the affected sets may cause
desanguination (blood loss), an under-delivery of prescribed medication/fluid, or a potential
delay in therapy. Continued use of the affected administration sets may cause a potential risk
of serious injury or death.

-----------------------------------------------------------------------------------------------------------------------------------------------PRODUCT

RECALL NUMBER
PRODUCT

1) Sterile wound closure strips, packaged as follows: DeRoyal Episeal, Wound Closure
Strips, REF 46-202, Sterile R, DeRoyal Episeal, Wound Closure Strips, REF 46-203, Sterile
R, DeRoyal Episeal, Wound Closure Strips, REF 46-204, Sterile R, DeRoyal Episeal,
Wound Closure Strips, REF 46-206, Sterile R, DeRoyal Episeal, Wound Closure Strips,
REF 46-212, Sterile R, DeRoyal Episeal, Wound Closure Strips, REF 46-213, Sterile R,
Wound Closure Strips, REF 46-214, STERILE R, DeRoyal Episeal, Wound Closure Strips,
REF 46-215, Sterile R, DeRoyal Episeal, Wound Closure Strips, REF 46-216, Sterile R
Z-1421-2012
2) Sterile surgical kits containing Episeal products, packaged as follows: DeRoyal CLINIC
PICC KIT, REF 47-483, STERILE EO, Rx Only, DeRoyal PICC DRESSING CHANGE
KIT, REF 47-491.12, STERILE EO, Rx Only, DeRoyal PICC KIT-NICU, REF 47-626.10,
STERILE EO, Rx Only, DeRoyal ST CENTRAL LN DRUG CHG KIT, REF 47-732.03,
STERILE EO, Rx Only, DeRoyal NICU PICC LINE KIT, REF 47-787.00, STERILE EO,
Rx Only, DeRoyal ORAL IMPLANT TRAY, REF 50-7104.05, STERILE EO, Rx Only,
DeRoyal A-LINE/CENTRAL LINE PLACEMENT, REF 50-7195.12, STERILE EO, Rx
Only, DeRoyal STEREO BREAST BIOPSY TRAY, REF 50-9786.03, STERILE EO, Rx
Only, DeRoyal BASIC BIOPSY TRAY, REF 50-12421.10, STERILE EO, Rx Only,
DeRoyal LAP CHOLE TRAY, REF 50-12892.09, STERILE EO, Rx Only, DeRoyal KNEE
ARTHROSCOPY TRAY, REF 50-12898.07, STERILE EO, Rx Only, DeRoyal NEURO
SPINE PACK, REF 50-13252.09, STERILE EO, Rx Only, DeRoyal BREAST BIOPSY
TRAY, REF 70-10770.05, STERILE EO, Rx Only, DeRoyal ANGIOGRAM TRAY4/CASE, REF 70-1911.20, STERILE EO, Rx Only, DeRoyal DIAGNOSTIC LAP BASIN,
REF 89-0323.06, STERILE EO, Rx Only, DeRoyal PLASTICS TRAY, REF 89-1918.07,
STERILE EO, Rx Only, DeRoyal LAP TUBAL VALUE SET, REF 89-2176.09, STERILE
EO, Rx Only, DeRoyal PACEMAKER TRAY, REF 89-2703.08, STERILE EO, Rx Only,
DeRoyal LAP GYN, REF 89-2995.10, STERILE EO, Rx Only, DeRoyal EXTREMITY
TRAY, REF 89-3053.11 and 89-3053.10, STERILE EO, Rx Only, DeRoyal SHOULDER
ARTHROSCOPY TRAY, REF 89-3190.10, STERILE EO, Rx Only, DeRoyal ENT EAR
TRAY, REF 89-3338.11, STERILE EO, Rx Only, DeRoyal CHILD CENTRAL LINE, REF
89-3351.07, DeRoyal SHUNT TRAY, REF 89-3452.07, STERILE EO, Rx Only, DeRoyal
LAMI/DISC PACK, REF 89-3472.08, STERILE EO, Rx Only, DeRoyal LAPAROTOMY
TRAY, REF 89-3482.06, STERILE EO, Rx Only, DeRoyal MINOR INTERVENTIONAL
TRAY, REF 89-3559.11, STERILE EO, Rx Only, DeRoyal MAJOR VASCULAR TRAY,
REF 89-6561.09, STERILE EO, Rx Only, DeRoyal ICD PACEMAKER TRAY, REF 893565.12 and 89-3565.13, STERILE EO, Rx Only, DeRoyal BREAST TRAY, REF 893564.06, STERILE EO, Rx Only, DeRoyal BREAST BIOPSY TRAY, REF 89-3831.10,
STERILE EO, Rx Only, DeRoyal ENDO SINUS TRAY, REF 89-3896.07, STERILE EO,
Rx Only, DeRoyal MP-004 STEREOTACTIC TRAY, REF 89-4003.04, STERILE EO, Rx
Only, DeRoyal BIOPSY TRAY MP-007, REF 89-4049.01, STERILE EO, Rx Only,
DeRoyal BREAST AUGMENTATION TRAY, REF 89-4087.02, STERILE EO, Rx Only,
DeRoyal SPINE PACK, REF 89-4150.05, STERILE EO, Rx Only DeRoyal KNEE
ARTHROSCOPY TRAY, REF 89-4185.08, STERILE EO, Rx Only, DeRoyal ACL TRAY,
REF 89-4195.08, STERILE EO, Rx Only, DeRoyal ACL TRAY, REF 89-4270.06,
STERILE EO, Rx Only, DeRoyal CARDIOVASCULAR PACK, REF 89-4712.09,
STERILE EO, Rx Only, DeRoyal CARDIOVASCULAR PACK, REF 89-4932.03,
STERILE EO, Rx Only, DeRoyal BREAST BIOPSY TRAY, REF 89-4955.04, STERILE
EO, Rx Only, DeRoyal ULTRA/MAMO TRAY, REF 89-4990.02, STERILE EO, Rx Only,
DeRoyal BREAST BIOPSY TRAY, REF 89-4955.04, STERILE EO, Rx Only, DeRoyal
LTX-SAFE STND-KNEE ARTHROSCOPY, STANDARD TRAY, REF 89-5032.01,
STERILE EO, Rx Only, DeRoyal STANDARD LAP CHOLE PACK, REF 89-5059.01,
STERILE EO, Rx Only, DeRoyal EXTREMITY TRAY, REF 89-5102.03, STERILE EO,
Rx Only, DeRoyal KNEE ARTHRO TRAY, REF 89-5103.03, STERILE EO, Rx Only,
DeRoyal CATARACT PACK PGYBK, REF 89-5173.01, STERILE EO, Rx Only, DeRoyal

RECALL NUMBER
PRODUCT
RECALL NUMBER

RETINA EYE TRAY, REF 89-5228.07, STERILE EO, Rx Only, DeRoyal

LAPAROSCOPIC CHOLE PACK, REF 89-5259.05, STERILE EO, Rx Only, DeRoyal
MINOR BASIN, REF 89-5293.07, STERILE EO, Rx Only, DeRoyal VEIN TRAY, REF
89-5341.01, STERILE EO, Rx Only, DeRoyal SHOULDER ARTHRO PACK, REF 895383.04, STERILE EO, Rx Only, DeRoyal KNEE ARTHROSCOPY PACK, REF 895488.02, STERILE EO, Rx Only, DeRoyal FISTULA / ARTERIOGRAM, REF 89-5545.02,
STERILE EO, Rx Only, DeRoyal VITRECTOMY PACK, REF 89-5559.08, STERILE EO,
Rx Only, DeRoyal LAP PACK, REF 89-5562.03, STERILE EO, Rx Only, DeRoyal
VENACURE PROCEDURE PACK, REF 89-5565.03, STERILE EO, Rx Only, DeRoyal
KNEE ARTHROSCOPY PACK, REF 89-5655.01, STERILE EO, Rx Only, DeRoyal
RETINA, REF 89-5657.04, STERILE EO, Rx Only, DeRoyal ACL PACK, REF 895687.01, STERILE EO, Rx Only, DeRoyal LAPAROSCOPY PACK, REF 89-5711.02,
STERILE EO, Rx Only, DeRoyal SHOULDER ARTHROSCOPY TRAY, REF 89-5820.01,
STERILE EO, Rx Only, DeRoyal BREAST BIOPSY TRAY, REF 89-5901.02, STERILE
EO, Rx Only, DeRoyal BASIC TRAY, REF 89-6211.01, STERILE EO, Rx Only, DeRoyal
LAPAROTOMY PACK, REF 89-6234.03, STERILE EO, Rx Only, DeRoyal
ENDOVENOUS PACK, REF 89-6344.02, STERILE EO, Rx Only, DeRoyal LAP CHOLE
PACK, REF 89-6397.04, STERILE EO, Rx Only, DeRoyal MIRIAM DEVICE TRAY, REF
89-6478.03, STERILE EO, Rx Only, DeRoyal VEIN PACK, REF 89-6509.01, STERILE
EO, Rx Only, DeRoyal VEIN PACK, REF 89-6642.03, STERILE EO, Rx Only, DeRoyal
VEIN TRAY, REF 89-6671.01, STERILE EO, Rx Only, DeRoyal LAPAROSCOPIC GYN
PACK, REF 89-6724.01, STERILE EO, Rx Only, DeRoyal ACL TRAY, REF 89-6814.03,
STERILE EO, Rx Only, DeRoyal KNEE ARTHROSCOPY TRAY, REF 89-6816.03,
STERILE EO, Rx Only, DeRoyal SHOULDER PACK, REF 89-6830.0510, STERILE EO,
Rx Only, DeRoyal CV TRAY, VENOUS & ARTERIAL SURGERY, REF 89-6844.02,
STERILE EO, Rx Only, DeRoyal IMPLANT PACK, REF 89-6981.03, STERILE EO, Rx
Only, DeRoyal LAPAROSCOPY PACK-LF, REF 89-7061.01, STERILE EO, Rx Only,
DeRoyal LAPAROSCOPIC ROBOTIC PACK, REF 89-7063.01, STERILE EO, Rx Only,
DeRoyal ORTHO SPORTS UCL SUPPLEMENTAL PACK, REF 89-7072.02, STERILE
EO, Rx Only, DeRoyal TORR VEIN TRAY, REF 89-7112.01, STERILE EO, Rx Only,
DeRoyal ACOUSTIC PACK, REF 89-7158.01, STERILE EO, Rx Only, DeRoyal BASIC
PACK, REF 89-7449.02, STERILE EO, Rx Only, DeRoyal ANGIOGRAPHY DRAPE
PACK, REF 89-7462.03, STERILE EO, Rx Only, DeRoyal HAND PACK, REF 897549.02, STERILE EO, Rx Only, DeRoyal ANGIOGRAPHY DRAPE PACK, REF 897613.01, STERILE EO, Rx Only, DeRoyal NERVE BLOCK TRAY, REF 89-7646.02,
STERILE EO, Rx Only, DeRoyal OASIS EYE PACK, REF 89-7688.01, STERILE EO, Rx
Only, DeRoyal PROGRESSIVE EYE PACK, REF 89-7693.02, STERILE EO, Rx Only,
DeRoyal NEONATAL/PED PICC INSERTION TRAY PGYBK, REF 89-7758.01,
STERILE EO, Rx Only, DeRoyal INTL-NEONATAL OPEN HEART PGYBK, REF 897871.01, STERILE EO, Rx Only, DeRoyal ENDOVENOUS PACK, REF 89-7762.01,
STERILE EO, Rx Only, DeRoyal BIOPSY PROCEDURE PACK, REF 89-7768.01,
STERILE EO, Rx Only, DeRoyal NEURO PACK, REF 89-7880.01, STERILE EO, Rx
Only, DeRoyal BIOPSY TRAY-MP-008, REF 89-7896, STERILE EO, Rx Only, GEOMED, PACEMAKER PACK, REF 89-6317.02, STERILE EO, Rx Only, GEO-MED,
ARTHROSCOPY PACK, REF 89-6371.03, STERILE EO, Rx Only, GEO-MED,
SHOULDER ARTHROSCOPY PACK, REF 89-6432.01, STERILE EO, Rx Only, GEOMED, NEURO LAMINECTOMY PACK, REF 89-6501.02, STERILE EO, Rx Only, GEOMED, ENT MINOR PACK, REF 89-6609.04, STERILE EO, Rx Only, GEO-MED,
PACEMAKER DEVICE PACK, REF 89-6643.01, STERILE EO, Rx Only, GEO-MED,
PACEMAKER PACK, REF 89-6717.02, STERILE EO, Rx Only, GEO-MED, MINOR
SURGICAL SET UP PACK, REF 89-7900.01, STERILE EO, Rx Only
Z-1422-2012
3) Non-sterile wound closure strips, packaged as follows: DeRoyal NS EPISEAL, Wound
Closure Strips, REF 46-202N, DeRoyal NS EPISEAL, Wound Closure Strips, REF 46204N, DeRoyal NS EPISEAL, Wound Closure Strips, REF 46-214N
Z-1423-2012

CODE

1) REF 46-202, Lot Number: 346935; REF 46-203, Lot Numbers: 345495, 362263; REF 46204, Lot Numbers: 350142, 344274; REF 46-206, Lot Numbers: 342708, 2360103; REF 46212, Lot Numbers: 352631, 345230; REF 46-213, Lot Number: 350152; REF 46-214, Lot
Numbers: 344278, 345232; REF 46-215, Lot Number: 345242; REF 46-216, Lot Numbers:
585961, 350276
2) REF 47-483, Lot Numbers: 27449271, 27199769, 26706212, 25465699, 25573374,
25750861, 25043496, 24808987; REF 47-491.12, Lot Numbers: 25402954, 25313425; REF
47-626.10, Lot Numbers: 27200029, 25573420, 25465752, 25750844, 25448039; REF 47732.03, Lot Numbers: 27449300, 26140642, 26023315, 25573876, 24525899; REF 47787.00, Lot Numbers: 27617924, 26733317, 25574596, 25362737, 25223251; REF 507104.05, Lot Numbers: 27559242, 27370028, 26754601, 26136539, 25490325; REF 507195.12, Lot Numbers: 27488798, 26742619, 26597992, 26414922, 26314711, 26270324,
26010477, 25893511, 25608717, 25369349, 25159165, 24832987, 24741575; REF 509786.03, Lot Numbers: 27489150, 27181278, 26676261, 26415634, 26599445, 26367361,
25609306, 25529701, 25358172, 25369533, 25024543; REF 50-12421.10, Lot Numbers:
26115201, 25697801, 25609031; REF 50-12892.09, Lot Numbers: 27473705, 27123297,
26971008, 26743099, 26384444, 26016941, 25609066, 25490165, 25357882, 25099537,
24853913; REF 50-12898.07, Lot Numbers: 27692561, 27489395, 27181850, 26863103,
26676981, 26280709, 26018760, 25558692, 25358560, 25100198, 24898599, 24747521;
REF 50-12892.09, Lot Numbers: 27855439, 27425480, 27181391, 26801375, 26394440,
26385009, 26115703, 24795522, 24662674; REF 70-10770.05, Lot Numbers: 27473713,
26278810, 26017249, 25308108, 25044931; REF 70-1911.20, Lot Numbers: 27728448,
26801084, 26497676, 26384639, 26017257, 25609314, 25358181, 25099836; REF 890323.06, Lot Numbers: 24746229, 24684662; REF 89-1918.07, Lot Numbers: 27609721,
27244718, 27180603, 26870768, 26813624, 26676341, 26384663, 26166771, 26017345,
25415341, 25099895, 25024631; REF 89-2176.09, Lot Numbers: 26384698, 26115439,
26062891, 25839574, 25764496, 25609381, 25358261, 25099932, 24662041; REF 892703.08, Lot Numbers: 27287005, 26923532, 26115973, 25610008, 25397593, 24898775,
25086031, 25100649; REF 89-2995.10, Lot Numbers: 27473756, 26840649, 25396911,
25024851, 24746421; REF 89-3053.1111 and 89-3053.10, Lot Numbers: 27890710,
27854997, 27776474, 27824528, 27750821, 27588781, 27470310, 27223482, 26839921,
26783648, 26662088, 26398053, 26015420, 25876421, 25697406, 25594693, 25529103,
25396312, 25458894, 24897393, 25272820, 25141766, 24833234, 24661604; REF 893190.10, Lot Numbers: 27473473, 27226667, 26956561, 26784430, 26475688, 26279100,
25697879, 25340095, 25201984, 25024957, 24746481; REF 89-3338.11, Lot Numbers:
27078369, 26980588, 26957724, 26785221, 25597034, 25086103, 24898804, 24855134;
REF 89-3351.07, Lot Numbers: 27197149, 26957732, 26729289, 26437972, 26394458,
26099037, 25878830; REF 89-3452.07, Lot Numbers: 25255245, 25308204; REF 893472.08, Lot Numbers: 27692406, 27227336, 26368612, 24775601; REF 89-3482.06, Lot
Numbers: 25086200, 25027533, 24650868; REF 89-3559.11, Lot Numbers: 27487218,
27342668, 27758487, 27286053, 26728091, 26279290, 26609877, 26125371, 25877458,
25459740, 25647396, 25415392, 25308255, 25220843, 25142291, 24898126, 24746579;
REF 89-3561.09, Lot Numbers: 27826064, 27648421, 27472711, 27408621, 27342684,
27286070, 27206332, 26956705, 27100335, 26784528, 26663241, 26578679, 26398504,
26279329, 26098190, 26017759, 25816743, 25647409, 25459758, 25340271, 25273507,
25142304, 25025132, 25025124, 24774705; REF 89-3565.12 and 89-3565.13, Lot
Numbers: 27610108, 27474345, 27425594, 27286942, 26801527, 27182043, 26664374,
26207931, 26063739, 25597376, 25460679, 25309063, 25203197; REF 89-3564.06, Lot
Numbers: 26958129, 26610114, 26553404, 26385367, 26437999, 25879277, 25648006,
25558916; REF 89-3831.10, Lot Numbers: 27649328, 27409033, 26956799, 26922821,
26728180, 26367652, 26098245, 25340360, 25084909; REF 89-3896.07, Lot Numbers:
25340394, 25220886, 24822498, 24806720; REF 89-4003.04, Lot Numbers: 27758541,
27472884, 27498363, 27226122, 27180283, 26956852, 26345031, 26017919, 25816786,
25764576, 25596015, 25025335, 24898214, 24854393, 24774828; REF 89-4049.01, Lot
Numbers: 25839700; REF 89-4087.02, Lot Numbers: 25876439, 25458923, 24915301; REF
89-4150.05, Lot Numbers: 25933077, 26093541, 25396347, 25083594, 25023196,

24853542; REF 89-4185.08, Lot Numbers: 25933077, 26093541, 25396347, 25083594,

25023196, 24853542; REF 89-4195.08, Lot Numbers: 27360882, 26077532, 25339174,
25121159; REF 89-4270.06, Lot Numbers: 27689629, 26955665, 26726934, 26366633,
25876501, 26097154, 26277104, 25839339, 25594749, 25697465, 25083674, 24821575;
REF 89-4712.09, Lot Numbers: 24599943, 25027710, 25027728, 25143227, 25342007,
25460601, 25597237, 25698521, 25745949, 25879058, 26020026, 26281699, 26398969,
26579073, 26664251, 26785361, 27181649, 27181657, 27197157, 27286838, 27370044,
27474193, 27759076, 27869195, 27903074, 27911752; REF 89-4932.03, Lot Numbers:
27225841, 26956001, 26727321, 25876914, 25339668, 25159499; REF 89-4955.04, Lot
Numbers: 27386441, 27180056, 26987173; REF 89-4990.02, Lot Numbers: 27968433,
27636050, 27473182, 27226405, 26728817, 26957370, 26648850, 26368225, 25878258,
25596533, 25558545, 25341101, 25369584, 25085557; REF 89-4955.04, Lot Numbers:
27386441, 27180056, 26987173; REF 89-5032.01, Lot Numbers: 27758292, 27244523,
27542272, 27035271, 26820613, 26985952, 26781562, 26270383, 26384057, 26166033,
26010573, 26077209, 25893562, 25873748, 25763717, 25414859, 25159202, 24741639,
24772347; REF 89-5059.01, Lot Numbers: 27892037, 27867886, 27825029, 27757759,
27741693, 27699376, 27589476, 27527355, 27527371, 27499198, 27407636, 27341446,
27285085, 27224354, 27178378, 26783031, 26800823, 26921182, 26954718, 26783023,
26725827, 26725819; REF 89-5102.03, Lot Numbers: 27700357, 26648876, 26078050,
26037910, 25866450, 25732849; REF 89-5103.03, Lot Numbers: 27648801, 27590522,
27528446, 27499260, 27310498, 27226325, 27100626, 26841078, 26663726, 26345306,
25698214, 25308511, 25142697, 24823108; REF 89-5173.01, Lot Numbers: 26821069,
26280451, 26018559, 25839849, 25698265, 25558617; REF 89-5228.07, Lot Numbers:
26764404, 26704321; REF 89-5259.05, Lot Numbers: 25142814, 25221011, 24974150;
REF 89-5293.07, Lot Numbers: 27970306, 27846524, 27206586, 27182431, 26923735,
26821122, 25916736, 25817682, 25397809, 25028181, 24899217; REF 89-5341.01, Lot
Numbers: 27221786, 26813472, 25893925, 25141475; REF 89-5383.04, Lot Numbers:
27697901, 27635807, 27385887, 27283397, 27310324, 27034420, 26955083, 26870602,
26726230, 26783373, 26632014, 26565296, 26226956, 26136256, 26090770, 25082946,
24820943; REF 89-5488.02, Lot Numbers: 26096813; REF 89-5545.02, Lot Numbers:
27174828, 26980668, 25879541, 25597632, 24916216, 24824653; REF 89-5559.08, Lot
Numbers: 27140126, 26366246, 26726424, 25876041, 25594247, 25415077, 25022249;
REF 89-5562.03, Lot Numbers: 27635831, 26986912, 26870611, 26366254, 26096848,
25916402, 25022257, 24953113, 24773690; REF 89-5565.03, Lot Numbers: 27930435,
27807197, 27587104, 27338706, 27488384, 27174772, 26345867, 26149495, 25698708,
25274673, 25028456, 24955371; REF 89-5655.01, Lot Numbers: 27930435, 27807197,
27587104, 27338706, 27488384, 27174772, 26345867, 26149495, 25698708, 25274673,
25028456, 24955371; REF 89-5657.04, Lot Numbers: 27220556, 26923815, 26369236,
26099635, 35242576; REF 89-5687.01, Lot Numbers: 27697531, 26345939, 26090921,
25597721; REF 89-5711.02, Lot Numbers: 27220652, 26958532, 26730212, 26566061,
25879681, 25840479, 25559089; REF 89-5820.01, Lot Numbers: 27467962, 27155598,
26726985, 26366668, 26062541, 25816233, 25529242, 25339246, 25099406; REF 895901.02, Lot Numbers: 25339220, 25307754, 25083711, 24853614; REF 89-6211.01, Lot
Numbers: 27499067, 24821815; REF 89-6234.03, Lot Numbers: 27902514, 27643268,
27369668, 27175193, 26783875, 26366879, 26277585, 25697596, 25307826, 25084010,
24923192, 24598861; REF 89-6344.02, Lot Numbers: 27339371, 27175450, 26785900,
26665035, 26566117, 26651397, 26021281, 25648461, 25531676, 25398211, 25359044,
25309397, 25203816, 25143972, 24916371, 24826430; REF 89-6397.04, Lot Numbers:
27423450, 26399435, 25880171, 25598272, 25343261, 25087819, 25029766; REF 896478.03, Lot Numbers: 27889866, 27608964, 27525771, 27468623, 27221655, 26842450,
26730870, 26476541, 26283811, 25880454, 25648612, 25343472, 25490632, 25030071,
24750455, 24663984; REF 89-6509.01, Lot Numbers: 27339581, 26275467, 25838985,
25696921, 25557112, 25338112; REF 89-6642.03, Lot Numbers: 27787528, 27698111,
26675381, 26726686, 26344311, 25083421, 25338948, 24853446; REF 89-6671.01. Lot
Numbers: 27222607, 27688896, 26100325, 26369973, 25880569, 25575919; REF 896724.01, Lot Numbers: 26284363, 25880737, 25294375, 25699356, 25088299, 24827838,

24750711, 24776760; REF 89-6814.03, Lot Numbers: 27902688, 27222834, 26094842,

25974215, 25777916, 25649738, 25019197, 24964568; REF 89-6816.03, Lot Numbers:
27255450, 27197026, 27176794, 26800778, 26723645, 26660058, 26394167, 26364021,
26314753, 26314745; REF 89-6830.05, Lot Numbers: 27750805, 27526782, 27340751,
27244195, 27197034, 27177367, 26952958, 26813261, 26781669, 26583700, 26061101,
26061098; REF 89-6844.02, Lot Numbers: 26364064, 26094922, 25080684, 25019234,
24922579; REF 89-6981.03, Lot Numbers: 27177375, 26836842, 26396921, 26660251,
26011120, 25080924, 24597260; REF 89-7061.01, Lot Numbers: 27757054, 27340419,
27176989, 26820656, 26660470, 26364494, 26095095, 25814959, 25592794, 25336977,
25019761; REF 89-7063.01, Lot Numbers: 27931139, 27178360, 26886276, 26820752,
26763997, 26724568, 26643186, 26565018, 26474503, 26397181, 26343722, 25748795,
25457841, 25268100; REF 89-7072.02, Lot Numbers: 27757071, 27645204, 26724242,
26396998, 26011533, 25744170, 24571140; REF 89-7112.01, Lot Numbers: 28036671;
REF 89-7158.01, Lot Numbers: 27757986, 27699641, 26764041, 26725405, 26598485,
26166279, 24597964; REF 89-7449.02, Lot Numbers: 27868117, 27845505, 27868109,
27527611, 27407943, 27285376, 27224821, 26921043, 26782813, 26661157, 26674821,
26644365, 26474888, 26365526, 26114823, 26096223, 26013475, 26013467, 25875137,
25696761, 25593535, 25506833, 25395811, 25337806, 25337793, 25255000, 25021191,
25140966, 24952541; REF 89-7462.03, Lot Numbers: 27224047, 26838856, 26725528,
26365518, 26096207, 25271915, 25140958, 25021174, 25021158, 24896454, 24852902,
24820441; REF 89-7549.02, Lot Numbers: 27757732, 27471030, 26783103, 26693116,
26437817, 26275205, 26147713, 26042330, 26014048, 25875330, 25593703; REF 897613.01, Lot Numbers: 27868512, 27776888, 27825889, 27700111, 27758372, 27670696,
27472403, 27342473, 27285940, 27179848, 26731362, 26652429, 26370296, 26284620,
26136803, 26064416, 26022380, 26022371, 25944622, 25840831, 25765341, 25699410,
25088475, 25030804, 24649883; REF 89-7646.02, Lot Numbers: 27776896, 27656501;
REF 89-7688.01, Lot Numbers: 25438130, 26097648; REF 89-7693.02, Lot Numbers:
26956166, 26922151, 26784069, 26727451, 26662635, 26662651, 26647048, 26344741,
26278123, 25647151, 26016537, 26016545, 25595389; REF 89-7758.01, Lot Numbers:
27609035, 27636826; REF 89-7871.01, Lot Numbers: 27911947, 27951818, 27962912,
28069245, 28076681; REF 89-7762.01, Lot Number: 27468981; REF 89-7768.01, Lot
Numbers: 27930662, 27823701, 27469079, 27176153, 27176145; REF 89-7880.01, Lot
Number: 28016899; REF 89-7896.01, Lot Number: 27993891; REF 89-6317.02, Lot
Numbers: 27823269, 27525510, 27339143, 27221153, 27175222, 26842177, 26730491,
26579591, 26664981, 26498871, 26369551, 26099969, 25866581, 25818028, 25648436,
25531633, 25398182, 25203761, 25087561, 25029512, 24826384, 24750050; REF 896371.03, Lot Numbers: 27468463, 26958938, 26730634, 26665123, 26566150, 26369682,
25880147, 25793289, 25598256, 25029723, 24855450, 24750228; REF 89-6432.01, Lot
Numbers: 27468501, 27175521, 26730773, 26638897, 26438043, 25029926, 25598344;
REF 89-6501.02, Lot Number: 27964281; REF 89-6609.04, Lot Numbers: 27222560,
26366457, 26315721, 26096952, 25876287, 25396232, 25201327; REF 89-6643.01, Lot
Numbers: 26344346, 26437876, 26147991, 25876279, 25022652, 25594554; REF 896717.02, Lot Numbers: 24643625, 24643617; REF 89-7900.01, Lot Numbers: 27981460,
27981494, 28016813, 28039
3) REF 46-202N, Lot Numbers: 26835591 and 25191755; REF 46-204N, Lot Numbers:
28084357, 28075961, 27003412, 27749425, 27392690, 26036749, 25731731, and
25235543; REF 46-214N, Lot Numbers: 27507573, 27437325, 26970419, 26970275,
26641033, 26394853, 26094578, 26009222, 25621209, 25235800, 25241960, 25120957,
25068811
MANUFACTURED & RECALLED BY
DeRoyal Industries, Inc. Lafollette, La Follette, TN
QUANTITY
205,661 units
DISTRIBUTION
Nationwide and Internationally
REASON
The adhesive backing on Episeal wound closure strips may not release from the backing
rendering the product unusable.

-----------------------------------------------------------------------------------------------------------------------------------------------PRODUCT

TrueBeam; Versions 1.0, 1.5.12.0 and below, 1.6.9.5 and below, provides sterotactic
radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the
body where radiation treatment is indicated. Model number H19
RECALL NUMBER
Z-1495-2012
CODE
Serial numbers: H191001 H191061 H191121 H191180 H191002 H191063 H191122
H191181 H191003 H191064 H191123 H191182 H191005 H191065 H191124 H191183
H191006 H191066 H191125 H191184 H191007 H191067 H191126 H191185 H191008
H191068 H191127 H191186 H191009 H191069 H191128 H191187 H191010 H191070
H191129 H191188 H191011 H191071 H191130 H191189 H191012 H191072 H191131
H191190 H191013 H191073 H191132 H191191 H191014 H191074 H191133 H191192
H191015 H191076 H191134 H191194 H191016 H191077 H191135 H191195 H191017
H191078 H191136 H191197 H191018 H191079 H191137 H191198 H191019 H191080
H191138 H191199 H191020 H191081 H191139 H191201 H191021 H191082 H191140
H191202 H191022 H191083 H191141 H191203 H191023 H191084 H191142 H191205
H191024 H191085 H191143 H191206 H191025 H191086 H191144 H191207 H191026
H191087 H191145 H191209 H191027 H191088 H191146 H191210 H191028 H191089
H191147 H191213 H191029 H191090 H191148 H191215 H191030 H191091 H191149
H191221 H191031 H191092 H191150 H191225 H191032 H191093 H191151 H191226
H191033 H191094 H191152 H191227 H191034 H191095 H191153 H191228 H191035
H191096 H191154 H191036 H191097 H191155 H191037 H191098 H191156 H191038
H191099 H191157 H191039 H191100 H191158 H191040 H191101 H191159 H191041
H191102 H191160 H191042 H191103 H191161 H191043 H191104 H191162 H191044
H191105 H191163 H191045 H191106 H191164 H191046 H191107 H191165 H191047
H191108 H191166 H191048 H191109 H191167 H191049 H191110 H191168 H191051
H191111 H191169 H191052 H191112 H191170 H191053 H191113 H191171 H191054
H191114 H191172 H191055 H191115 H191174 H191056 H191116 H191175 H191057
H191117 H191176 H191058 H191118 H191177 H191059 H191119 H191178 H191060
H191120 H191179
MANUFACTURED & RECALLED BY
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA
QUANTITY
207 devices
DISTRIBUTION
Nationwide and Internationally
REASON
A software anomaly has been identified in TrueBeam when using respiratory gating with
patients in the prone position. The gating curve is inverted when a prone patient plan is
loaded into TrueBeam.
-----------------------------------------------------------------------------------------------------------------------------------------------PRODUCT

Crystal Metal Disposable Blades size Mac 4 (part number 50674, 50674/F, 50674/BMI) and
Mac 3 (part numbers 50675, 50675/F, 50675/BMI), disposable laryngoscope blades.
RECALL NUMBER
Z-1221-2012
CODE
All lots with expiration dates between August 2011 and August 2016.
MANUFACTURED & RECALLED BY
Penlon, Ltd., Abingdon, United Kingdom
QUANTITY
24,940 cartons
DISTRIBUTION
Nationwide and Internationally
REASON
Disposable laryngoscope blades incorrectly labeled with wrong size.
-----------------------------------------------------------------------------------------------------------------------------------------------PRODUCT
RECALL NUMBER
CODE
RECALLED BY

Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option
Intended use: Stationary radiographic system, Radiographic system, digital. Model #s
712020, 712022, 712082
Z-1464-2012
version 2.x
Philips Healthcare Inc., Andover, MA

10

MANUFACTURER
QUANTITY
DISTRIBUTION
REASON

Philips Medical Systems GmbH, DMC, Hamburg, Germany

606 units (153 units US and 453 units international)
Nationwide and Internationally
Potential misdiagnosis due to improperly automatically stitched images improper image
ruler handling.

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Dimension Vista Total Prostate Specific Antigen Flex reagent cartridge, an in vitro
diagnostic test for the quantitative measurement of total prostate specific antigen (PSA) in
human serum and plasma on the Dimension Vista System. Catalog number: K6451;
Mnemonic: TPSA
RECALL NUMBER
Z-1540-2012
CODE
Lot number 11300BB, exp 10/26/2012
MANUFACTURED & RECALLED BY
Siemens Healthcare Diagnostics, Inc., Newark, NJ
QUANTITY
1,103 cartons
DISTRIBUTION
Nationwide and PR
REASON
Siemens has confirmed a report of leaking Flex reagent cartridge lot 11300BB from
Dimension Vista TPSA; when a leaking Flex is used, patient test results may be falsely
depressed.
-----------------------------------------------------------------------------------------------------------------------------------------------PRODUCT
RECALL NUMBER
PRODUCT

RECALL NUMBER
CODE

RECALLED BY
MANUFACTURER
QUANTITY
DISTRIBUTION
REASON

1) S.M.A.R.T. Transhepatic Biliary Stent, Catalog C06120MB; Catalog C06150MB;

Catalog C07120 MB; Catalog C07150MB; Catalog C08120MB; Catalog C08150MB.
Indicated for palliation of malignant neoplasms in the biliary tree.
Z-1507-2012
2) S.M.A.R.T. Control Transhepatic Biliary Stent, Catalog C10080MB; Catalog C10080SB;
Catalog C12030SB; Catalog C12040SB; Catalog C12060SB; Catalog C12080MB; Catalog
C14040SB; Catalog C14060SB; Catalog C14080SB, for palliation of malignant neoplasms
in the biliary tree
Z-1508-2012
1) Lot No's. 15530111, 15535366, 15556361, 15560541, 15562698; 15530115, 15536150,
15556366, 15560543; 15530114, 15556368, 15560545, 15562701; 15530113, 15556371,
15560546; 15530112; 15535365, 15556374, 15562702
2) Lot No's. 15535360, 15530747, 15530756, 15530755, 15535363, 15569685, 15530757;
15530754, 15557313; 15530753, 15557311; 15535361
Cordis Corp., Miami Lakes, FL
Cordis de Mexico, S.A. de C.V., Chihuahua, Mexico
1,262 units
Nationwide and Canada
There is a potential for a sterility breach due to holes or tears in the Tyvek packaging.

-----------------------------------------------------------------------------------------------------------------------------------------------PRODUCT

ABL80FLEX Blood Gas, pH, Electrolyte, and Metabolite System, a portable, automated
analyzer that measures pH, blood gases, electrolytes, glucose, and hematocrit in whole
blood, model number: 393-839 for ABL80 FLEX analyzers
RECALL NUMBER
Z-1384-2012
CODE
Serial number(s): 304157, 304160 and 304162 to 305414
MANUFACTURED & RECALLED BY
SenDx Medical Inc., Carlsbad, CA
QUANTITY
819 analyzers and 44 signal data PCBs of Part number 903-227
DISTRIBUTION
OH and Internationally
REASON
The product can cause the analyzer to report values outside the published performance
specifications for pH, pCO2, cNa+, cK+, cCa2+ and cCl-.

11

-----------------------------------------------------------------------------------------------------------------------------------------------PRODUCT
RECALL NUMBER
CODE
RECALLED BY
MANUFACTURERS
QUANTITY
DISTRIBUTION
REASON

Coloplast, Restorelle DirectFix, Posterior Polypropylene Mesh, Catalogue Number 501460,

a ploypropylene mesh that may be used for the repair of abdominal wall hernia, including
inguinal, fermoral, and incisional, and uterovaginal proplapse and other fascial deficiencies
Z-1481-2012
Lot numbers: 2936642, 2967400
Coloplast Manufacturing US, LLC, Minneapolis, MN
Coloplast A/S, Humlebaek, Denmark; Culzean Medical Devices Limited, Prestwick, UK
134 units
Nationwide
Two lots of Restorelle DirectFix Posterior mesh were mislabeled. The incorrect size was
printed on the patient label. Specifically the patient label depicts the size as 16x11 cm,
however, the correct size is actually 14x15 cm. It is important to note that both the product
and box labels were correct.

-----------------------------------------------------------------------------------------------------------------------------------------------PRODUCT

RECALL NUMBER
CODE
RECALLED BY
MANUFACTURER
QUANTITY
DISTRIBUTION
REASON

Evolution steam sterilizers, consisting of two major components: -Loading Car: Shelving
unit which holds the items to be sterilized; and the -Transfer Carriage: Wheeled unit which
loads/unloads the loading car and transports it from one location to another. Model #:
M4012097, M4012098, M4011084, M4011085 & M4011090.
Z-1522-2012
Seral #s: 030400905 thru 030381235
Steris Corp., Mentor, OH
Steris Mexico, Guadalupe, Mexico
523 units
Nationwide and Internationally
Operators may experience difficulty when inserting or removing equipment from the
Evolution sterilizer using the transfer carriage due to the following issues with the transfer
carriage. 1) Deformation of the latch pin or cracked ball bearings preventing the roller from
turning. 2) The rollers on the ends of the pivot arms can impact the bottom of the cam slot or
draft against the slot if the arms are not adjusted properly. The current design requires
precise field adjustments in order to function reliably. 3) Wear of the pins and chamber track
surface due to use as the carriage rail pins drag against the sides of the tracks during use. 4)
Dislodging of the clips that are located in the elevator assembly and used to lift/lower the
cart each cycle.

-----------------------------------------------------------------------------------------------------------------------------------------------PRODUCT
RECALL NUMBER
CODE
RECALLED BY
MANUFACTURER
QUANTITY
DISTRIBUTION
REASON

Fresenius Liberty Cycler Software, User Manuals, and Handi-Guides for acute and chronic
peritoneal dialysis; Software versions earlier than 2.8, product codes: Cyclers: 180020,
180111 User Manuals: 480001 Handi-Guides: 480017
Z-1448-2012
All machines operating on software versions earlier than version 2.8
Fresenius Medical Care Holdings, Inc., Waltham, MA
Fresenius USA, Inc., Walnut Creek, CA
10,146 units
Nationwide
Increased risk of intraperitoneal volume (IIPV), referred to as Overfill.

-----------------------------------------------------------------------------------------------------------------------------------------------PRODUCT

Siemens-branded ONCOR or PRIMUS linear accelerator with an OPTIVUE or MVision

imaging system; model #s: ONCOR Expression 7360717, ONCOR Impression Plus
5857912, medical charged-particle radiation therapy system

12

RECALL NUMBER
CODE
RECALLED BY
MANUFACTURER
QUANTITY
DISTRIBUTION
REASON

Z-1494-2012
All units of these models.
Siemens Medical Solutions USA, Inc., Concord, CA
Siemens Ag Medical Solutions, Kemnath, Germany
73 units
Nationwide
The firm became aware of a potential issue with Siemens-branded ONCOR or PRIMUS
linear accelerator with an OPTIVUE or MVision imaging system that has the potential
collision problem of the imaging panel if the panel does not retract before the gantry rotates;
this may result in patient injury.

-----------------------------------------------------------------------------------------------------------------------------------------------PRODUCT
RECALL NUMBER
CODE
RECALLED BY
MANUFACTURER
QUANTITY
DISTRIBUTION
REASON

Vacuum Tissue Processor, Model ASP6025; an automated modular tissue processor, an

automated system used to process tissue specimens for examination through fixation,
dehydration, and infiltration
Z-1473-2012
Serial numbers 162, 163, 168, 169, 170, 171, 182, 183, 184, 200 through 267
Leica Microsystems, Inc., Buffalo Grove, IL
Leica Biosystems Nussloch GmbH, Nussloch, Germany
27 units - U.S., 40 units - Internationally
Nationwide and Internationally
There is a potential malfunction with the device in autorotation mode, which can lead to
incorrect reagent handling of the device. The end result may lead to damage or to loss of
tissue specimens.

-----------------------------------------------------------------------------------------------------------------------------------------------PRODUCT

RECALL NUMBER
CODE

RECALLED BY
MANUFACTURER
QUANTITY
DISTRIBUTION
REASON

Galil Medical, 17G Cryoablation Needle Holder FPRPR 4014, Rx only; Sterile EO, for use
only with a Galil Medical Needle Testing Device (NTD); the NTD, a component used when
performing cryogenic destruction of tissue with a Galil Medical Cryoablation System, is
intended for performing a Needle Integrity and Functionality Test in preparation for a
cryoablation procedure
Z-1613-2012
N8185-001; N9438-001; N9438-003; N9438-004; N7890-003; N7975-001; N7975-002;
N8185-006; N8185-007; N7729-005; N7890-004; N9438-002; N8185-005; N8185-008;
N7890-005; N7975-003; N7729-001; N7729-002; N8185-009; N8185-010; N7729-003;
N7729-004; N7890-001; N7890-002; N7975-004; N7975-005
Galil Medical, Inc., Arden Hills, MN
Galil Medical Ltd., Yokneam, Israel
26 kits
Nationwide and Internationally
The possibility of excessive bioburden on the Needle Holders

-----------------------------------------------------------------------------------------------------------------------------------------------PRODUCT
RECALL NUMBER
CODE
RECALLED BY
MANUFACTURER
QUANTITY
DISTRIBUTION
REASON

Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM-197 Protein); Prevnar 13;

One Dose (0.5 mL) for IM use only; NDC 0005-1971-01
B-1348-12
Lot: F73652
Pfizer Inc., New York, NY
Pfizer Inc., Pearl River, NY
67,770 units
GA
Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine 0.5mL, formulated and filled with
an expired serotype 3 conjugate material, was distributed.

13

-----------------------------------------------------------------------------------------------------------------------------------------------PRODUCT

Celestone brand of betamethasone Oral Solution USP, 0.6 mg/ 5 mL, supplied in 4 fluid
ounce (118 mL) amber glass bottles, Rx only, NDC 0085-0942-05
RECALL NUMBER
D-1354-2012
CODE
LOT 9 APR 101, EXP AUG 12; LOT 9 APR 102, EXP SEP 12; LOT 9 APR 103, EXP
NOV 12; LOT 0 APR 100, EXP MAR 13; LOT 0 APR 101, EXP JUN 13; LOT 0 APR 102,
EXP SEP 13; LOT 0 APR 103, EXP SEP 13
MANUFACTURED & RECALLED BY
Merck, Inc., Kenilworth, NJ
QUANTITY
96,033 glass bottles
DISTRIBUTION
Nationwide and Puerto Rico
REASON
Failed Content Uniformity Requirements; potential for dosing variability found during
routine product stability testing
------------------------------------------------------------------------------------------------------------------------------------------------

14