Health product recall

Maquet Quadrox-i Oxygenators and Perfusion Packs

Last updated

Summary

Product
Maquet Quadrox-i Oxygenators and Perfusion Packs
Issue
Medical devices - Sterility
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 Adult Oxygenator W/Integrated Hardshell Reservoir

More than 10 numbers, contact manufacturer.

VKMO 71000
VKMO 70000

Perfusion Set With Softline Coating

3000267224
3000297817
3000282071
3000263899
3000277366
3000306549
3000316377
3000315697

BO-HQV 46904
BO-HQV 55812
BO-HQV 55813

Perfusion Pack

3000252905

HQV 94500

Custom Pack With Softline

More than 10 numbers, contact manufacturer.

BO-HQV 59206
BO-HQV 55004
BO-HQV 56114

Perfusion Set With Bioline Coating

More than 10 numbers, contact manufacturer.

BEQ-HQV 46904
BEQ-HQV 65008
BEQ-HQV 52700-1

Issue

Potential for a foreign particle in the VHK 71000 reservoir.  This reservoir can be stand alone or a component in several different custom tubing packs. The issue is limited to products manufactured before June 21, 2023.

Recall start date: July 15, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Health products - Medical devices - General hospital and personal use
Companies

Maquet Cardiopulmonary GmbH

Kehler Strasse 31, Rastatt, Germany, 76437

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75865

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