| Class 2 Device Recall Steerable Coronary Sinus Catheter |  |
Date Initiated by Firm | June 15, 2011 |
Date Posted | July 11, 2011 |
Recall Status1 |
Terminated 3 on June 01, 2012 |
Recall Number | Z-2777-2011 |
Recall Event ID |
59135 |
510(K)Number | K023880 K981909 |
Product Classification |
Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
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Product | Steerable Coronary Sinus Catheter, Model SCS01, 9 Fr x 20.4", Sterile R, Edwards Lifesciences Port Access Systems.
Device is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible with the catheter contamination guard, is packaged with these catheters. |
Code Information |
Lot numbers: 678238B, 751043B, 755821B, 763122B. |
Recalling Firm/ Manufacturer |
Edwards Lifesciences, LLC 12050 Lone Peak Pkwy Draper UT 84020-9414
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For Additional Information Contact | 801-565-6100 |
Manufacturer Reason for Recall | Possibility of separation of the introducer sheath from the hub on Coronary Sinus Catheters. |
FDA Determined Cause 2 | Employee error |
Action | Edwards Lifesciences, LLC sent an Urgent Product Recall - Action Required letter dated June 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Cusotmers were instructed to check their inventory for any affected product and return all unused product from their stock to Edwards at:
Edwards Lifesciences
12060 Lone Peak Pkwy
Draper, UT 84020
Attention: Suzanne Carpenter, RGA #
Customers were instructed to contact Customer Service to obtain a Returned Goods Authorization number and replacement product . Once customers verified their inventory, they were to complete the attached form and fax it to Edwards at (949) 250-3489. For any questions customers were instructed to call Edwards Customer Service at (800) 424-3278. |
Quantity in Commerce | 97 units |
Distribution | Nationwide Distribution. |
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 510(K)s with Product Code = DWF
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