Integra Dermal Regeneration Template-TS Catalog number 32021 Catalog number 82021
This recall has been terminated (originally issued March 6, 2009).
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- January 16, 2009
- Posted
- March 6, 2009
- Terminated
- June 25, 2009
- Recall Number
- Z-1035-2009
- Quantity
- 31 units
- Firm Location
- Plainsboro, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained.
Distribution
Nationwide Distribution -- including states of FL, CA, GA, FL, CT, MT, IL, TX, WA, TN, NC, IN, AZ, MD, CO, MO, and TN.
Lot / Code Info
Lot Numbers: 105BA0134826 and 105BB0134826. Lot Numbers: 105BY0134826 and 105BW0134826.
Root Cause
Pending
Action Taken
Urgent: Product Recall Notification letters were sent on January 21, 1009 via Federal Express. The letter asked customers to immediately quarantine any stock on hand and contact their local Integra Sales Representative for further assistance and arrangement of product returns. The enclosed "Recall Acknowledgement and Return Form" indicating whether or not customers possess any of the affected product should also be completed and returned. Company is conducting recall to the hospital level. Questions should be directed to Judy O'Grady at 609-936-2317.