Z-1856-2012 Class II Terminated
FDA device recall Z-1856-2012 was initiated by Genzyme Corporation on June 13, 2012 and is designated Class II. Reason for recall: Sterility of product may be compromised due to packaging defect The recall status is terminated (terminated July 24, 2013). Affected quantity: 1285 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 27, 2012
- Initiation Date
- June 13, 2012
- Termination Date
- July 24, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1285 units
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
Distribution Pattern
Worldwide Distribution - US (nationwide) and the country of S. Korea
Code Information
Lot number: 11NP685 . Exp 2014- 11