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U.S. Department of Health and Human Services

Class 2 Device Recall Edwards Protection Cannulae Monitoring and Infusion Set

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  Class 2 Device Recall Edwards Protection Cannulae Monitoring and Infusion Set see related information
Date Initiated by Firm October 19, 2010
Date Posted December 07, 2010
Recall Status1 Terminated 3 on May 18, 2011
Recall Number Z-0543-2011
Recall Event ID 57143
510(K)Number K892377  
Product Classification Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass - Product Code DTL
Product Edwards Protection Cannulae - Monitoring and Infusion Set, Model MIS004, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614.
Code Information Lot No.: 58832055, 58896850, 58916757
Recalling Firm/
Manufacturer		 Edwards Lifesciences Llc
12050 Lone Peak Parkway
Draper UT 84020-9414
For Additional Information Contact
801-565-6195
Manufacturer Reason
for Recall		 Monitoring and Infusion Set connectors may break during manipulation.
FDA Determined
Cause 2		 Employee error
Action Edwards Lifesciences issued a Urgent Product Recall letter dated October 13, 2010 to customers identifying the affected devices, requesting the return of unused devices and completion and return of a response form. Further information is available at 800-424-3278.
Quantity in Commerce 570 sets
Distribution Nationwide Distribution: in the states of FL, KS, MO, TX, VA, and PR.
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 = DTL and Original Applicant = RESEARCH MEDICAL, INC.
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