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U.S. Department of Health and Human Services

Class 2 Device Recall Steerable Coronary Sinus Catheter

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  Class 2 Device Recall Steerable Coronary Sinus Catheter see related information
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
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
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
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) Database 510(K)s with Product Code = DWF and Original Applicant = BAXTER EDWARDS
510(K)s with Product Code = DWF and Original Applicant = ETHICON, INC.
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