Recall Z-1856-2012— Genzyme Corporation
Class II · Terminated
Class II FDA medical device recall by Genzyme Corporation, initiated 2012-06-13, terminated 2013-07-24. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Sterility of product may be compromised due to packaging defect.
- Recalling firm
- Genzyme Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-06-13
- Terminated
- 2013-07-24
- Firm location
- Framingham, MA, United States
Product description
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.
Reason for recall
Sterility of product may be compromised due to packaging defect
Data sourced from openFDA. This site is unofficial and independent of the FDA.