Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip Anastomotic Device Removal Tool is designed to remove U-Clip Anastomotic Devices.
This recall has been terminated (originally issued June 27, 2007).
- Recall Initiated
- February 8, 2007
- Posted
- June 27, 2007
- Terminated
- February 24, 2008
- Recall Number
- Z-0968-2007
- Quantity
- 187 (US 155, OUS 32)
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Six lots of U-Clip Removal Tools, catalog REM1860FW were incorrectly assembled. The nose cone attachment to the body of the removal tool does not contain sufficient adhesive which can cause the nose to separate from the body of the device.
Distribution
Nationwide and Canada.
Lot / Code Info
lot numbers: 0610707, 0614409, 0614410, 0614411, 0614412, 0622204
Root Cause
Other
Action Taken
Customers to be notified via a letter on 2/8/07. The letter will explain the situation and requests that the impacted product be returned to Medtronic for disposal. The customer will be requested to complete a "Recall Certificate" acknowledging the receipt of this information.
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