Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV), sterile EO, Rx Only, Synovis Surgical Innovations, A Division of Synovis Life Technologies, Inc, 2575 University Ave W., St Paul, MN 55114-1024. The device is intended to be used as a staple line buttress
This recall has been terminated (originally issued November 23, 2011).
- Recall Initiated
- October 26, 2011
- Posted
- November 23, 2011
- Terminated
- April 24, 2012
- Recall Number
- Z-0274-2012
- Quantity
- 132 units
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Synovis Surgical Innovations is voluntarily recalling one lot of Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V) product because some of the devices were mislabeled.
Distribution
Nationwide Distribution including CT, GA, NJ, NY, OH, TX, VA.
Lot / Code Info
Lot # 5784583-1590912
Root Cause
Labeling mix-ups
Action Taken
Synovis Surgical Inovation sent a "Recall Notification" letter dated October 26, 2011. The letter described the problem and product affected. Customers were instructed to identify and quarantine the affected product and to complete and fax the Product Return/Replacement Form.
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