Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement. Do not reuse. Ethylene Oxide Sterilized. Made in the U.S.A. Synovis Surgical Innovations A division of Synovis Life Technologies, Inc., 2575 University Ave. W., St. Paul, MN 55114-1024 USA.
This recall has been terminated (originally issued April 13, 2006).
- Recall Initiated
- November 1, 2005
- Posted
- April 13, 2006
- Terminated
- February 3, 2007
- Recall Number
- Z-0764-06
- Quantity
- 4,950
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
The Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement devices involved have a small chance that a seal on the outer pouch may not be completely reliable.
Distribution
Nationwide. AK, AZ, CA, FL, GA, IA, IL, MA, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and VA
Lot / Code Info
Lot number: 5710119-175140, 5710790-180727, 5710941-181455, 5710942-181456, 5711046-181820, 5711047-18121, 5711227-183395, 5711397-185711, 5711448-186781, 5711724-190560, 5711777-191665, 5711930-194095, 5712202-197704, 5712203-197705, 5712254-198709, 5712255-198710, 5712256-198711, 5712965-220245, 5713055-221862, 5713056-221864, 5713059-221867, 5713060-221868, 5713061-221869, 5713261-225636, 5713419-227238, 5713420-227239, 5713657-230645, 5713658-230646, 5713789-235178, 5714079-239059, 5714507-246886, 5714566-247028, 5714665-252591, and 5714901-255263. Six pouches of unknown lot number hand carried to the University of Chicago as well as 12 pouches to the University of Missouri.
Root Cause
Other
Action Taken
An initial phone call was placed to expedite return and replacement of product. A follow-up letter was sent. The initial phone calls to customers began on November 1, 2005.