Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement. Do not reuse. Ethylene Oxide...
Synovis Surgical Inovation Div. of began a recall of 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... on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-0764-06
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.)
- Product
- 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.
- Product code
- FTM Mesh, Surgical
- 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.
- Root cause tag
- packaging
- FDA root cause
- Other
- Action
- 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.
- Quantity in commerce
- 4,950
- Distribution
- Nationwide. AK, AZ, CA, FL, GA, IA, IL, MA, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and VA
- Product codes and lots
- 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.
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