Reported Jun 27, 2012 · Terminated
seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is…
Genzyme Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Genzyme Corporation · 31,45,49,51,55,74,76, & 80 New York Ave. · Framingham, MA · 01702-5733
Is this the product you have?
- seprafilm¿ Procedure
- Pack ADHESION BARRIER Re-order Number5086-02
- Product UsageSeprafilm 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 adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder
- Lot codes and dates
- Lot numbers
11NP620 Exp. 2014 - 0911NP630 Exp 2014 - 10and 11NP649 Exp 2014- 1111NP704 Exp 2014 - 11
- Lot numbers
- Amount recalled
- 3880units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Sterility of product may be compromised due to packaging defect
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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