FDA Enforcement
Class II
Terminated
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.
Recall: Z-1856-2012
·
Reported June 27, 2012
Enforcement
- Recall Number
- Z-1856-2012
- Event ID
- 62127
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Genzyme Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 27, 2012
- Initiation Date
- June 13, 2012
- Classification Date
- June 21, 2012
- Termination Date
- July 24, 2013
- Address
- 31,45,49,51,55,74,76, & 80 New York Ave., N/A, Framingham, MA, 01702-5733, United States
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
Sterility of product may be compromised due to packaging defect
Code Info
Lot number: 11NP685 . Exp 2014- 11
Distribution
Worldwide Distribution - US (nationwide) and the country of S. Korea
Quantity
1285 units