Health product recall

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