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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 Device 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
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 NJ 07470
Manufacturer Reason
for Recall
ELS 15 Fr Cannula could potentially contain an occluded arterial lumen.
FDA Determined
Cause 2
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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