Health product recall

Quadrox-I/-Id Oxygenators

Last updated

Summary

Product
Quadrox-I/-Id Oxygenators
Issue
Medical devices - Performance issue
Medical devices - Sterility Issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Quadrox-I Neonatal Oxygenator With Integrated Hardshell Reservoir 3000284972 VKMO 11000
Quadrox-I Adult Oxygenator More than 10 numbers, contact manufacturer. HMO 70000 HMO 71000
Quadrox-I Small Adult (With Bioline) 3000257100 BEQ-HMO 51000
Quadrox-Id Adult Oxygenator (With Bioline) More than 10 numbers, contact manufacturer. BEQ-HMOD 70000-USA
Quadrox-Id Adult Oxygenator (With Bioline) More than 10 numbers, contact manufacturer. HMOD 70000-USA

Issue

Maquet Cardiopulmonary GmbH (MCp) became aware of various failure modes in regard to the Quadrox-I/-Id, vhk 11000 and vkmo 10000/ 11000 products in the course of six non-conformity reports. The identified failure modes can be divided into two categories: a potentially compromised sterile barrier and a deviation from the coating specifications.

Recall start date: March 28, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Health products - Medical devices - Cardiovascular
Companies

Maquet Cardiopulmonary GmbH

Kehler Strasse 31, Rastatt, Germany, 76437

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73461

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