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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-1094-06
Recall Event ID 35291
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
ProductAortic Perfusion Cannula with Metal Tip, 22 Fr. x 23 cm. , Edwards Lifesciences
Code Information REF: MT022A. Lot numbers 58209961, 58193894, 58203989, 58213564.
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 overmolded plastic portion of the metal 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 Commerce26 units (Domestic), 420 units (Foreign)
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.
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