Recall Z-1174-2009 ยท FRO Dressing, Wound, Drug
Integra LifeSciences Corp.
Integra Bilayer Matrix Wound Dressing, 8 in X 10 in (20 cm x 25 cm); Non-pyrogenic, Do not Re sterilize, Store flat at room temperature, Avoid Excessive heat, Avoid freezing. Sterile. Catalog number BMW810. Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536, USA.
| Date | Apr 7, 2009 (initiated Mar 10, 2009) |
| Status | Terminated |
| Reason | Package Seal Integrity: Integra became aware of the potential of open seals in the foil pouch of the Integra Bilayer Matrix Wound Dressings. |
| Root cause | Nonconforming Material/Component |
| Action | Urgent: Product Recall Notification letters, dated March 10, 2009, were sent out by first class mail to all consignees. The letters asked consignees to quarantine any stock on hand and contact their local Integra Sales Representative for further assistance and for arrangement of product returns. Consignees also need to complete and return the "Recall Acknowledgement and Return Form" indicating whether or not they possess any affected product. Additional questions should be directed to Judith O'Grady at 609-936-2311. |
| Quantity | 125 units |
| Distribution | Nationwide Distribution -- including states of CA, FL, MN, TX, NC, GA, NY, OH, MI, NE, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021792 | BILAYER MATRIX WOUND DRESSING Integra Lifesciences Corp., Aug 14, 2002 |