Events

Recall of Device Recall Maquet QuadroxID Pediatric Diffusion Membrane Oxygenator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Maquet Cardiovascular Us Sales, Llc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69795
  • Event Risk Class
    Class 2
  • Event Number
    Z-0870-2015
  • Event Initiated Date
    2014-11-05
  • Event Date Posted
    2014-12-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131553
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Oxygenator, cardiopulmonary bypass - Product Code DTZ
  • Reason
    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.
  • Action
    Maquet Inc. sent Urgent Product Recall - Removal Letters/Response Forms dated 11/5/2014.

Device

Device Recall Maquet QuadroxID Pediatric Diffusion Membrane Oxygenator
  • Model / Serial
    k100278 Lot number 70100610
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in DC, MA, & MI.
  • Product Description
    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.
  • Manufacturer
    Maquet Cardiovascular Us Sales, Llc

Manufacturer

Maquet Cardiovascular Us Sales, Llc
  • Manufacturer Address
    Maquet Cardiovascular Us Sales, Llc, 45 Barbour Pond Drive, Wayne NJ 07470
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA