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Class 2 Device Recall Millar MikroTip Disposable Angiographic Catheter (Left Heart) |
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Date Initiated by Firm |
October 14, 2010 |
Date Posted |
November 17, 2010 |
Recall Status1 |
Terminated 3 on February 15, 2011 |
Recall Number |
Z-0401-2011 |
Recall Event ID |
57015 |
510(K)Number |
K952773 K993694
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Product Classification |
Catheter, intravascular, diagnostic - Product Code DQO
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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 TX 77023
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For Additional Information Contact |
713-923-9171
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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.
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FDA Determined Cause 2 |
Packaging |
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
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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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510(K) Database |
510(K)s with Product Code = DQO and Original Applicant = MILLAR INSTRUMENTS, INC.
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