Class 2 Device Recall Edwards Protection Cannulae Monitoring and Infusion Set

• Date Initiated by Firm: October 19, 2010
• Date Posted: December 07, 2010
• Recall Status: Terminated 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: 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