• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of February 27, 2013

  • Print
  • Share
  • E-mail
-

Event Detail

Event ID 64288
Product Type Devices
Status Ongoing
Recalling Firm Maquet Cardiovascular Us Sales, Llc
City Wayne
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-26
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants. 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 Class II ELS 15 Fr Cannula could potentially contain an occluded arterial lumen. 41 units - US Distirbution; 216 units - OUS Distribution Z-0839-2013
-
-