FDAFDA · Food and drugs·Recall number Z-1855-2012
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.
Published June 27, 2012 · Recall initiated: June 13, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sterility of product may be compromised due to packaging defect
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Genzyme Corporation
- Distributor
- Worldwide Distribution - US (nationwide) and the country of S. Korea
- Lot
- Lot numbers: 11NP620 Exp. 2014 - 09; 11NP630 Exp 2014 - 10; and 11NP649 Exp 2014- 11; 11NP704 Exp 2014 - 11
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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