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U.S. Department of Health and Human Services

Class 2 Device Recall MikroTip

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  Class 2 Device Recall MikroTip see related information
Date Initiated by Firm January 14, 2005
Date Posted March 18, 2005
Recall Status1 Terminated 3 on December 19, 2006
Recall Number Z-0635-05
Recall Event ID 30967
510(K)Number K993694  
Product Classification Catheter, Intravascular, Diagnostic - Product Code DQO
Product Mikro-Tip Disposable Angiographic Catheter manufactured by Millar Instruments, Houston, Texas
Code Information Lot numbers L034403 and L034731
Recalling Firm/
Manufacturer
Millar Instruments, Inc
6001-A Gulf Fwy
Houston TX 77023
Manufacturer Reason
for Recall
Wire braiding protruding from the catheter.
FDA Determined
Cause 2
Other
Action The firm initiated the recall via e-mail to direct accounts on 01/14/2005 and letter on 01/20/2005.
Quantity in Commerce 28 catheters
Distribution Product was distributed to distributors and hospitals in MN, CA, and NY.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DQO and Original Applicant = MILLAR INSTRUMENTS, INC.
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