Maquet Quadrox-i Oxygenators and Perfusion Packs
Brand(s)
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
Get notified
Receive notifications for new and updated recalls and alerts by category.