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U.S. Department of Health and Human Services

Class 2 Device Recall QUADROXi(D) Oxygenator

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 Class 2 Recall
QUADROXi(D) Oxygenator
see related information
Date Posted October 26, 2012
Recall Status1 Open
Recall Number Z-0160-2013
Recall Event ID 62947
Premarket Notification
510(K) Numbers
K071774  K082117  K090511  K090689  K093522  K100278 
K101153  K102464  K103191  K112360 
Product Classification Oxygenator, Cardiopulmonary Bypass - Product Code DTZ
Product QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The devices utilization period is limited to six hours.
Code Information All sizes and membrane types of QUADROX-i oxygenators, i.e., QUADROX-i(D) Adult, Small Adult, Pediatric and Neonatal with SOFTLINE and BIOLINE Coating; Catalogue numbers to include BE-HMOD XXXXX; BEQ-HMO XXXXX; BEQ-HMOD XXXX; BEQ-HMOD XXXXX; BO-VKMO XXXXXX; HMO XXXX; HMO XXXXX; HMOD XXXX; HMOD XXXXX; VKMO XXXX; VKMO XXXXX; X HMO XXXXX U; XHMOD 30000 U; X VKMO XXXXX U; and X 1895. QUADROX-iR with SOFTLINE and BIOLINE Coating - Catalogue numbers to include XVIVO HMO 70100 U. HLS module 5.0 and 7.0 in HLS Sets: Catalogue numbers to include BEQ-HLS 5050 and BEQ-HLS 7050. HLS module 5.0 and 7.0 in HIT HLS Sets: Catalogue numbers to include BO-HLS 5050 and BO-HLS 7050. Custom Tubing Packs containing oxygenators listed above: Catalogue numbers to include TOP XXXXX; TOP XXXXXns; TOP XXXX; BO-TOP XXXXX; BEQ TOP XXXXX; BSQ-TOP XXXX; and BSQ-TOP XXXXX. Note: an X was used to represent variations of catalogue numbers.
Recalling Firm/
Manufacturer
Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Drive
Wayne, New Jersey 07470
For Additional Information Contact Ms. Susan Mandy
201-995-8968
Manufacturer Reason
for Recall
It has come to firm's attention that, in some rare cases, the blood outlet connector on some models of MAQUET Oxygenators may detach from the oxygenator. This event has occurred in about 0.01% (1:10,000) of units shipped.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Maquet sent a Field Safety Notices and Confirmation Forms dated June 13, 2012 to all affected customers. A Follow-up communication dated July 20, 2012 was mailed to all affected US customers. The Field Safety Notice identifies the problem, affected product, risk factors and actions to be taken by the customer. Customers were instructed to complete the Confirmation form and return in the self-addressed prepaid envelop. For questions call 201-995-8968. Maquet issued an updated Field Safety Notice/Field Safety Notice Confirmation Form dated 2/14/13 via Fed Ex on 2/18/2013. Maquet sent out an Updated Field Safety Notice/field Safety Notice Confirmation Form dated 4/4/2013 in order to notify customers they would be providing safety clamps.
Quantity in Commerce 23,203 units
Distribution US Nationwide Distribution
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 = DTZ and Original Applicant = MAQUET CARDIOPULMONARY AG
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