Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, ( PSD 21-U-V), 21mm, US Surgical Staplers. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip
This recall has been terminated (originally issued June 15, 2007).
- Recall Initiated
- March 16, 2007
- Posted
- June 15, 2007
- Terminated
- February 24, 2008
- Recall Number
- Z-0963-2007
- Quantity
- 85
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Package Integrity/Sterility Compromised-The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise the sterility of the outside of the tray in which the device is packaged.
Distribution
Nationwide including states of AZ, CA, CT, FL, IA, IL, IN, KY, MA, MI, MN, MO, NJ, NY, OH, OK, PA, TN, TX, VA, and WI
Lot / Code Info
5713057-221865, 5713421-227240, 5727945-538783, 5728518-547271. EXPANDED SERIAL/LOT#'s: 5728518-560761 and 5729324-562206
Root Cause
Other
Action Taken
Recall notification letters were sent to hospitals via Federal Express on 03/16/2007. This letter describes the product being recalled and problem. It requests consignees to complete and fax back the product return form. EXPANDED Another recall letter dated 04/23/2007 was sent to inform customers of 17 aditional lot numbers being recalled. A third recall letter dated 05/05/2007 was set to hospitals to inform them of one additional Lot/Serial number that was affected. This letter also requests a product return form be completed and faxed to Synovis Surgical Innovations.