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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic UClip

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 Class 2 Device Recall Medtronic UClipsee related information
Date Initiated by FirmFebruary 08, 2007
Date PostedJune 27, 2007
Recall Status1 Terminated 3 on February 24, 2008
Recall NumberZ-0968-2007
Recall Event ID 37300
510(K)NumberK031623 
Product Classification Anastomotic Device Removal Tool - Product Code FZP
ProductMedtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip Anastomotic Device Removal Tool is designed to remove U-Clip Anastomotic Devices.
Code Information lot numbers: 0610707, 0614409, 0614410, 0614411, 0614412, 0622204
FEI Number 3003368396
Recalling Firm/
Manufacturer		 Medtronic Cardiac Surgery Technologies
7601 Northland Dr N
Minneapolis MN 55428-1088
Manufacturer 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 2		Other
ActionCustomers 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.
Quantity in Commerce187 (US 155, OUS 32)
DistributionNationwide and Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FZP
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