Device 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.
Z-1856-2012
Product summary
- Event
- Event 62127
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1285 units
- Official record key
device-enforcement:Z-1856-2012
Official wording
Reason: Sterility of product may be compromised due to packaging defect
Code information: Lot number: 11NP685 . Exp 2014- 11
Distribution pattern: Worldwide Distribution - US (nationwide) and the country of S. Korea
Derived failure modes
-
Labeling or packaging
packaging defect
-
Sterility assurance
Sterility of product may be compromised due to packaging defect