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U.S. Department of Health and Human Services

Class 2 Device Recall Millar MikroTip Disposable Angiographic Catheter (Left Heart)

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 Class 2 Recall
Millar MikroTip Disposable Angiographic Catheter (Left Heart)
see related information
Date Posted November 17, 2010
Recall Status1 Terminated on February 15, 2011
Recall Number Z-0401-2011
Recall Event ID 57015
Premarket Notification
510(K) Numbers
K952773  K993694 
Product Classification Catheter, Intravascular, Diagnostic - Product Code DQO
Product Millar Disposable Angiographic Catheter (Left Heart), manufactured for Millar Instruments, Inc 6001-A Gulf Freeway, Houston, Texas 77023
Code Information Catalog-Models: SPC-454D, SPC-454E, SPC-454F, SPC-464D. Product Code/Part No.: 800-4219-1, 800-4219-2, 800-4219-3, 802-1029X. Lot No.: L057674, L064963, L057687, L062222, L061409, L057687, L065039, L058763. S/N: 407126, 407128, 493801, 391962, 466255, 466256, 435426, 391965, 391968, 493756, 425284, 425285.
Recalling Firm/
Manufacturer
Millar Instruments, Inc
6001-A Gulf Fwy
Houston, Texas 77023
Manufacturer Reason
for Recall
The sterile packaging was found to be compromised when tested after shipping conditions. This may result in infection or transmission of disease. A test for transportation of sterile package was conducted and resulted in several samples failing.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Millar issued a Recall Report letter on October 14, 2010 to consignees identifying the affected product, sterility issue, and actions to be taken. Customers are to return all unused catheters to Millar for replacement. Customers can contact Millar about this recall at 832-667-7131.
Quantity in Commerce 12 Units
Distribution Worldwide Distribution: USA, including the states of MA, OH, PA, and D.C., and the countries of Canada 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 = DQO and Original Applicant = MILLAR INSTRUMENTS, INC.
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