QUADROX-I PEDIATRIC OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR (2020-12-21)
- Starting date:
- December 21, 2020
- Posting date:
- December 31, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-74691
Last updated:
2020-12-31
Affected Products
QUADROX-I PEDIATRIC OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR
Reason
During verification testing of pediatric VKMOS and VHKS a potential impairment of the sterile packaging barrier system was identified.
Affected products
QUADROX-I PEDIATRIC OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- VKMO 30000
- BO-VKMO 31000
- VKMO 31000
Companies
- Manufacturer
-
MAQUET CARDIOPULMONARY GMBH
KEHLER STR. 31, RASTATT, GERMANY, 76437
RASTATT
76437
GERMANY