Quadrox-I/-Id Oxygenators
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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 |
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
Maquet Cardiopulmonary GmbH
Kehler Strasse 31, Rastatt, Germany, 76437
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