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Genzyme Corporation recalls seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indic
Recalled June 27, 2012 · FDA recall Z-1856-2012 · Genzyme
Hazard
Sterility of product may be compromised due to packaging defect · FDA Class II
Units
1285 units
Sold at
Worldwide Distribution - US (nationwide) and the country of S. Korea
Description
Sterility of product may be compromised due to packaging defect
Product
seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 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 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.
Manufacturer(s)
Genzyme Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →