—#80200

Product

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.

FDA product code: FRO — Dressing, Wound, Drug
Device class: Class U
Medical specialty: Unknown
510(k) numbers: K021792
Affected lot / code info: Lot number 105BA0105205

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: Nationwide Distribution -- including states of CA, FL, MN, TX, NC, GA, NY, OH, MI, NE, and PA.

Timeline

Recall initiated: 2009-03-10
Posted by FDA: 2009-04-07
Terminated: 2009-06-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #80200. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.