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Class 2 Device Recall Aortic Perfusion Cannula |
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Date Initiated by Firm |
April 18, 2006 |
Date Posted |
June 09, 2006 |
Recall Status1 |
Terminated 3 on June 11, 2008 |
Recall Number |
Z-1091-06 |
Recall Event ID |
35291 |
510(K)Number |
K831769
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Product Classification |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
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Product |
Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm Edwards Lifesciences |
Code Information |
REF: ARH221190TA. Lot numbers 58196967, 58199178. |
Recalling Firm/ Manufacturer |
Edwards Lifesciences Research Medical, Inc. 6864 Cottonwood St Midvale UT 84047-1083
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For Additional Information Contact |
801-565-6100
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Manufacturer Reason for Recall |
Due to potential embrittlement of the plastic tip which may crack or separate during use.
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FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by letter and visit beginning 04/18/2006. |
Quantity in Commerce |
190 units (Domestic), 800 units (Foreign). |
Distribution |
CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU, India, Singapore, Taiwan |
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 = DWF and Original Applicant = RESEARCH INDUSTRIES CORP.
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