Quadrox-I/-Id Oxygenators
Brand(s)
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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