Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-15GPS . Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 15 mm, 250 mm long. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024
This recall has been terminated (originally issued July 24, 2007).
- Recall Initiated
- June 19, 2007
- Posted
- July 24, 2007
- Terminated
- May 8, 2012
- Recall Number
- Z-1082-2007
- Quantity
- 1box (4 units)
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside.
Distribution
Nationwide.
Lot / Code Info
5729974-575784
Root Cause
Other
Action Taken
Consignees were sent a letter on June 19, 2007. The letter identified the product and problem. The letter also included a form for inventory purposes which is to be completed and faxed to Synovis.
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