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Class 2 Device Recall Edwards Protection Cannulae Monitoring and Infusion Set |
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Date Initiated by Firm |
October 19, 2010 |
Date Posted |
December 07, 2010 |
Recall Status1 |
Terminated 3 on May 18, 2011 |
Recall Number |
Z-0542-2011 |
Recall Event ID |
57143 |
510(K)Number |
K892377
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Product Classification |
Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass - Product Code DTL
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Product |
Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614 |
Code Information |
Lot No.: 58803802, 58851054, 58881366 |
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
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Manufacturer Reason for Recall |
Monitoring and Infusion Set connectors may break during manipulation.
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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 |
322 sets |
Distribution |
Nationwide Distribution: in the states of FL, KS, MO, TX, VA, and PR. |
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 = DTL and Original Applicant = RESEARCH MEDICAL, INC.
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