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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Percutaneous Catheter Introducer Set

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 Class 2 Recall
Medtronic Percutaneous Catheter Introducer Set
see related information
Date Posted December 02, 2008
Recall Status1 Open
Recall Number Z-0442-2009
Recall Event ID 50078
Premarket Notification
510(K) Number
K955785 
Product Classification Introducer, Catheter - Product Code DYB
Product 6 F BardSelect 11cm Percutaneous Catheter Introducer Set Ref: 060A11 Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a catheter through the skin into a vein or artery. Percutaneous introducers are recommended for initial percutaneous introduction or the exchange of intravascular devices. Guide wire introducer needles are used for percutaneous puncture and insertion into the blood vessel. The guide wire is then inserted through the cannula of the introducer needle at the puncture site. The cannula is then removed to allow insertion of the percutaneous catheter introducer following removal of the guide wire introducer needle.
Code Information Lot Number: 20105869 and 20111254
Recalling Firm/
Manufacturer
Medtronic, Inc.
35-37A Cherry Hill Drive
Danvers, Massachusetts 01923-2565
For Additional Information Contact SAME
978-777-0042
Manufacturer Reason
for Recall
Failure to insert the guidewire through the 18 gauge introducer needle
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Medtronic notified Medtronic Sales representatives via UPS for hand delivery of the Urgent Notification of Product Recall letter to the affected customers on 10/7/08 advising users to segregate the product so that it would not be used. The letter stated that a Medtronic Sales Rep would visit the site to account for all units that were received and would initiate a credit, as appropriate. Customers were requested to cooperate and assist with completing the necessary documentation.
Quantity in Commerce 2,585 units
Distribution Worldwide Distribution --- USA including states of IL and FL, and countries of Belgium, Honduras, and Germany.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = C.R. BARD, INC.
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