Integra Bilayer Matrix Wound Dressing, 8 in X 10 in (20 cm x 25 cm); Non-pyrogenic, Do not Re sterilize, Store flat at r
FDA device recall Z-1174-2009 · posted 2009-04-07 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Package Seal Integrity: Integra became aware of the potential of open seals in the foil pouch of the Integra Bilayer Matrix Wound Dressings.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FRO
- Quantity affected
- 125 units
- Distribution
- Nationwide Distribution -- including states of CA, FL, MN, TX, NC, GA, NY, OH, MI, NE, and PA.
- Date initiated
- 2009-03-10
- Date posted
- 2009-04-07
- Date terminated
- 2009-06-26
- Location
- Plainsboro, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BILAYER MATRIX WOUND DRESSING (K021792) | Integra Lifesciences Corp. | 2002-08-14 |