Recall Z-1855-2012
Genzyme Corporation · initiated June 13, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
seprafilm Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 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.
Codes / lots: Lot numbers: 11NP620 Exp. 2014 - 09; 11NP630 Exp 2014 - 10; and 11NP649 Exp 2014- 11; 11NP704 Exp 2014 - 11
Reason for recall
Sterility of product may be compromised due to packaging defect
FDA-determined cause: Packaging process control
Action taken
Genzyme issued an Urgent: Medicatical Device Product Recall Notification Letter dated June 13, 2012 to all affected customers. Stericycle Expert Solutions, will be acting on behalf of Genzyme to coordinate notifications, communications, and logistics for returns of all product subject to this recall. The letter identified the affected products, problen and actions to be taken. Customers are requested to check their inventory and return all affected products per the instructions provided. Customers are instructed to complete the enclosed Business Reply Form and return via fax transmission to 866-912-2519. For questions call Stericycle at: 877- 473-7069.
Details
- Recall number
- Z-1855-2012
- Initiated
- June 13, 2012
- Posted by FDA
- June 21, 2012
- Terminated
- July 24, 2013
- Product code
- MCN – Barrier, Absorbable, Adhesion
- Quantity
- 3880units
- Distribution
- Worldwide Distribution - US (nationwide) and the country of S. Korea
- Recalling firm
- Genzyme Corporation, Framingham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1856-2012 Class II | seprafilm Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm…Sterility of product may be compromised due to packaging defect | 06/13/2012Terminated |