Recall Z-0968-2007
Medtronic Cardiac Surgery Technologies · initiated February 8, 2007
Product
Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip Anastomotic Device Removal Tool is designed to remove U-Clip Anastomotic Devices.
Codes / lots: lot numbers: 0610707, 0614409, 0614410, 0614411, 0614412, 0622204
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.
FDA-determined 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.
Details
- Recall number
- Z-0968-2007
- Initiated
- February 8, 2007
- Posted by FDA
- June 27, 2007
- Terminated
- February 24, 2008
- Product code
- FZP – Clip, Implantable
- Quantity
- 187 (US 155, OUS 32)
- Distribution
- Nationwide and Canada.
- Recalling firm
- Medtronic Cardiac Surgery Technologies, Minneapolis, MN