Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0764-06

Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement. Do not reuse. Ethylene Oxide...

SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) / initiated 2005-11-01 / Terminated / root cause: packaging

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.