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U.S. Department of Health and Human Services

Class 3 Device Recall Zinetics Manometric catheter

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 Class 3 Device Recall Zinetics Manometric cathetersee related information
Date Initiated by FirmApril 06, 2006
Date PostedJune 22, 2006
Recall Status1 Terminated 3 on January 16, 2007
Recall NumberZ-1159-06
Recall Event ID 35094
Product Classification manometric catheter - Product Code KLA
ProductMedtronic Zinetics Manometric Catheter, Model 9012P2271. Water perfused, motility catheter. Distributed by Medtronic, Inc. 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604 USA.
Code Information Lots 0001391 and 0001464
Recalling Firm/
Manufacturer		 Medtronic Gastroenterology / Urology
4000 Lexington Ave N
Shoreview MN 55126-2917
For Additional Information ContactTechnical Support
800-227-3191
Manufacturer Reason
for Recall		Mislabeling- The 8 ports of the manometric catheter were incorrectly labeled 1,3,5,7,8,2,4,6 from the distal to the proximal end of the catheter. The correct port configuration is sequentially 1 through 8, from the distal to the proximal end of the catheter.
FDA Determined
Cause 2		Other
ActionRecall initiated to International accounts on 04/05/06 and within US on 04/06/06 via an Urgent Recall Notification. The letter informs them of the manufacturing defect, requests return for credit of any unused inventory and requests accounting of all previously used catheters. Distributors are instructed to sent a letter to their customers to request product return.
Quantity in Commerce94 catheters (US - 4; OUS - 90)
DistributionWorldwide Distribution-including states of IL, NC, NY. and countries of Austria, Chile, Finland, Germany, Greece, Hong Kong, Italy, Japan, Lebanon, Norway, Peru, Portugal, Saudi Arabi, Spain
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.
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