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U.S. Department of Health and Human Services

Class 2 Device Recall ELS Cannula 15 FR

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 Class 2 Recall
ELS Cannula 15 FR
see related information
Date Posted February 20, 2013
Recall Status1 Terminated on May 08, 2014
Recall Number Z-0839-2013
Recall Event ID 64288
Premarket Notification
510(K) Number
K002857 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.
Code Information US Distribution Part number 701017471 Lot numbers 92046825 92065723 92076940 OUS Distribution Part Number Lot Numbers 701002797 92050616 701002797 92052823 701002797 92052913 701002797 92058153 701002797 92063518 701002797 92068260 701002797 92069267 701002797 92072177 701002797 92075413 701002797 92077862 701005092 92081862 701005092 92049129 701005092 92070554 701005093 92049130 701005093 92056899 701005093 92065588 701005093 92069429 701005093 92070553 701005093 92071852 701005093 92073598 701005093 92076875 701017471 92076940 701046644 92063587 701050978 92047882 701050978 92053930 701050978 92054156 701050978 92056171 701050978 92056804 701050978 92065094 701050978 92067382 701050978 92068224 701050978 92069286 701050978 92071806
Recalling Firm/
Manufacturer
Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Drive
Wayne, New Jersey 07470
Manufacturer Reason
for Recall
ELS 15 Fr Cannula could potentially contain an occluded arterial lumen.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Maquet sent Urgent Device Recall Letters/Recall Acknowledgement Forms to their customers on 12/26/2012.
Quantity in Commerce 41 units - US Distirbution; 216 units - OUS Distribution
Distribution Worldwide Distribution-USA including the states of AZ, CO, FL, TN, and TX and the countries of Australia, Canada, Czech Republic, Dubai/Bahrain/Kuwait/Lebanon/Saudi Arabia/Yemen, France, Germany, Hong Kong, Italy, Japan, Netherlands, Singapore, South Africa, Sweden, Switzerland, Thailand, Turkey, and UK.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = JOSTRA AG
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