Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V), 4506 ETS-V. PSD-V is an implantable surgical mesh comprised of non-crosslinked bovine pericardium in a dehydrated form. Do not reuse. Consult Instructions for Use. Sterilized. Product treated with sodium hydroxide. Produt derived from USDA-inspected cattle. Made in the U.S.A. Rx Only. Synovis Surgical Innovations A Division of Synovis Life Technologies, Inc., 6575 University Ave W., St. Paul, MN 55114-1024 USA. 651 796-7300, 800.487.9627
This recall has been terminated (originally issued June 14, 2005).
- Recall Initiated
- May 23, 2005
- Posted
- June 14, 2005
- Terminated
- November 17, 2005
- Recall Number
- Z-0891-05
- Quantity
- 320 boxes each box containing 6 pouches
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Device is contained in 2 pouches. The outer pouch's seal may be compromised; this may render the exterior of the interior pouch non-sterile.
Distribution
AK, AL, AZ, CA, DE, FL, GA, MO, OR, TN, TX, VA and WA
Lot / Code Info
Lot Number: 5707464-166925, 5707598-118352, 5708605-151644, 5708622-152524, 5708624-152526, 5709355-167627, 5709825-173142, 5709826-173143 and 5709827-173144
Root Cause
Other
Action Taken
The sites and/or distributors that received the suspect devices were contacted by telephone and given instruction how to return/replace the devices. A Recall Notice, dated 05/31/05, was also sent to customers indicating the model number(s) and quantities of affected product which the institution received and the amount they were to return.