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U.S. Department of Health and Human Services

Class 2 Device Recall Seprafilm

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 Class 2 Device Recall Seprafilmsee related information
Date Initiated by FirmApril 10, 2008
Date PostedAugust 24, 2008
Recall Status1 Terminated 3 on September 29, 2015
Recall NumberZ-1648-2008
Recall Event ID 47758
PMA NumberP950034 
ProductSeprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier). Japan Distribution Only Product Number: 4301-05
Code Information Lot number: 07NP181 Exp June 2010
FEI Number 1220423
Recalling Firm/
Manufacturer		 Genzyme Corporation
45, 51-80 New York Ave and
One Mountain Rd.
Framingham MA 01701
For Additional Information Contact
508-872-8400
Manufacturer Reason
for Recall		Sterility may be compromised
FDA Determined
Cause 2		Employee error
ActionGenzyme notified Distributors and hospitals by letter dated 4/10/08, requesting ceasing distribution and return recalled product.
Quantity in Commerce517 (10 packs)
DistributionNationwide Korea, Taiwan, Japan
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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