| Class 2 Device Recall Aortic Perfusion Cannula | |
Date Initiated by Firm | April 18, 2006 |
Date Posted | June 09, 2006 |
Recall Status1 |
Terminated 3 on June 11, 2008 |
Recall Number | Z-1094-06 |
Recall Event ID |
35291 |
Product Classification |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
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Product | Aortic 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
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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 |
Action | Consignees were notified by letter and visit beginning 04/18/2006. |
Quantity in Commerce | 26 units (Domestic), 420 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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