(FSCA)

FOOD AND DRUG ADMINISTRATION

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. (HPVC-MD-FSCA No.) ......................................

(Field Safety Corrective Action)

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3.11 (product owner) ................................................................................................................................................
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1.3 HPVC-MD-FSCA No.

4 (FSCA) 8 2
FSCA57123456
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1.
1.1
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1.7
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3.4 / (Model No.)
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3.6 (Serial No.)

3.7 (Lot/Batch No.)
3.8 (Cat. /Part No.)
AE .doc

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3.9 / ()
3.10 (physical manufacturer)

3.11 (product owner)

4.
4.1
1.
2.
(2.1)
(serious public health concern)
/ (serious injury)
(death)
/ (non-serious injury)
(2.2)

4.2 (health hazard evaluation report)
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AE .doc

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