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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet QuadroxID Pediatric Diffusion Membrane Oxygenator

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  Class 2 Device Recall Maquet QuadroxID Pediatric Diffusion Membrane Oxygenator see related information
Date Initiated by Firm November 05, 2014
Date Posted December 24, 2014
Recall Status1 Terminated 3 on July 24, 2015
Recall Number Z-0870-2015
Recall Event ID 69795
510(K)Number K100278  
Product Classification Oxygenator, cardiopulmonary bypass - Product Code DTZ
Product Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000

For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature.
Code Information k100278 Lot number 70100610
Recalling Firm/
Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Drive
Wayne NJ 07470
For Additional Information Contact
Manufacturer Reason
for Recall
Maquet has confirmed through a customer complaint that while the oxygenators and the pouches for a single lot of Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioliine Coating are labeled correctly with the Bioline coating, the individual cartons and 4-pack shipping containers of this lot incorrectly bear Softline coating labels instead of the bioline coating labels.
FDA Determined
Cause 2
Process control
Action Maquet Inc. sent Urgent Product Recall - Removal Letters/Response Forms dated 11/5/2014.
Quantity in Commerce 28 units
Distribution Distributed in DC, MA, & MI.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DTZ and Original Applicant = MAQUET CARDIOPULMONARY AG