| Class 2 Device Recall Aortic Cannula | |
Date Initiated by Firm | January 21, 2011 |
Date Posted | May 13, 2011 |
Recall Status1 |
Terminated 3 on May 13, 2011 |
Recall Number | Z-2196-2011 |
Recall Event ID |
57951 |
510(K)Number | K033463 |
Product Classification |
Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
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Product | Edwards Aortic Perfusion Cannula with Duraflow Coating, REF: DARH201190TA, 20 Fr. x 28 cm, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614.
The cannula perfuses blood to the ascending aorta during short-term (<6 hours) cardiopulmonary bypass procedures. The device is a Duraflo coated cannula intended for use in cardiopulmonary surgery when a heparin coated blood path is desired. |
Code Information |
Lot Number: 58946275 |
Recalling Firm/ Manufacturer |
Edwards Lifesciences Llc 12050 Lone Peak Parkway Draper UT 84020-9414
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For Additional Information Contact | 801-565-6195 |
Manufacturer Reason for Recall | Bonding of the tip to the aortic cannula tubing may decline over time and may contribute to a drop in bond strength. Possible tip separation. |
FDA Determined Cause 2 | Other |
Action | The firm, Edwards Lifesciences, sent an "URGENT PRODUCT RECALL - ACTION REQUIRED" letter dated January 21, 2011 it customers via Fed-Ex. The letter described the product, problem and actions to be taken. The customers were instructed to check their inventory for any of the lot numbers; return all unused product from their stock to Edwards; contact their Customer Service Organization at (800) 424-3278 to obtain a Returned Goods Authorization number and replacement product; complete and return the Aortic Perfusion Cannula Recall Response form via fax to: Edwards at (949) 250-3489, and return unused product to Edwards Lifesciences, 12050 Lone Peak Drive, Draper, UT 84020.
If you have questions that have not been answered by this letter, call Edwards Customer Service at (800) 424-3278 from 8:00AM - 4:30PM Pacific Time. |
Quantity in Commerce | 20 |
Distribution | Nationwide distribution: CA only. |
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
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