Z-1855-2012 Class II Terminated
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
- 3880units
Product Description
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.
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 numbers: 11NP620 Exp. 2014 - 09; 11NP630 Exp 2014 - 10; and 11NP649 Exp 2014- 11; 11NP704 Exp 2014 - 11