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U.S. Department of Health and Human Services

Class 2 Device Recall Aortic Perfusion Cannula

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 Class 2 Device Recall Aortic Perfusion Cannulasee related information
Date Initiated by FirmApril 18, 2006
Date PostedJune 09, 2006
Recall Status1 Terminated 3 on June 11, 2008
Recall NumberZ-1089-06
Recall Event ID 35291
510(K)NumberK831769 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
ProductAortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm Edwards Lifesciences
Code Information REF: A3221190A. Lot Number 58194673
Recalling Firm/
Manufacturer
Edwards Lifesciences Research Medical, Inc.
6864 Cottonwood St
Midvale UT 84047-1083
For Additional Information Contact
801-565-6100
Manufacturer Reason
for Recall
Due to potential embrittlement of the plastic tip which may crack or separate during use.
FDA Determined
Cause 2
Other
ActionConsignees were notified by letter and visit beginning 04/18/2006.
Quantity in Commerce320 units (Domestic)
DistributionCA, 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 CycleTPLC 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) Database510(K)s with Product Code = DWF
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