Reported Jun 27, 2012 · Terminated
seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated…
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¿ Single
- Site ADHESION BARRIER Re-order Number6641-01
- 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 number11NP685 . Exp 2014- 11
- Amount recalled
- 1285 units
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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