Genzyme Recalls Seprafilm Adhesion Barrier Packs Due to Packaging Defect
Genzyme is recalling Seprafilm Procedure Packs because a packaging defect may compromise the product's sterility. The recall affects units distributed in the US and South Korea.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential loss of sterility in a medical device used during surgery, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Genzyme Corporation is recalling Seprafilm Procedure Packs (Adhesion Barrier) due to a packaging defect that may compromise the sterility of the product. The affected product is indicated for use in patients undergoing abdominal or pelvic laparotomy to reduce postoperative adhesions.
The recall involves 3,880 units distributed nationwide in the United States and in South Korea. The specific lot numbers affected are 11NP620, 11NP630, 11NP649, and 11NP704, with expiration dates ranging from September to November 2014.
Healthcare providers and patients should stop using the affected Seprafilm Procedure Packs and contact Genzyme Corporation for further instructions or a replacement.
The recalled product
- Product
- seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adh
- Manufacturer
- Genzyme Corporation
- Affected units
- 3,880
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot numbers: 11NP620 Exp. 2014 - 09
- 11NP630 Exp 2014 - 10
- and 11NP649 Exp 2014- 11
- 11NP704 Exp 2014 - 11
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Genzyme Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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