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U.S. Department of Health and Human Services

Class 2 Device Recall QUADROX Oxygenator

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 Class 2 Recall
QUADROX Oxygenator
see related information
Date Posted September 20, 2013
Recall Status1 Open
Recall Number Z-2262-2013
Recall Event ID 66049
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. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
Code Information QUADROX-iD Adult catalog number HMOD 70000, lot # 70081567 QUADROX-i Adult catalog number VKMO 70000, lot # 70082663 QUADROX-i Adult catalog number VKMO 71000, lot # 70083974
Recalling Firm/
Manufacturer
Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Drive
Wayne, New Jersey 07470
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond strength on the inlet and/or outlet connector.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Maquet sent a Urgent Product Recall letter/Response Form, dated 8/15/2013 via Fed Ex. On 8/26/2013 Maquet sent a letter to their customers informing them that all shipments of oxygenators and stainless steel hold clamps have been placed on a temporary hold due to an agency review in connection with FDA clearance. Customer service may be contacted at 1-888-627-8383, (option 2 followed by option 2) Monday though Friday between the hours of 8:00 am and 6:00 pm EST. Maquet issued a Certificate of Medical Neccesity (CMN) on September 17, 2013 to notify Quadrox customers that they may continue to receive and use their current inventory of Quadrox oxygenators and clamps by acknowledging the conditions provided in the CMN.
Quantity in Commerce 1,182 units
Distribution Worldwide Distribution, including Nationwide (US) and foreign countries.
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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