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Quadrox and Quadrox-I Oxygenators and Supplies (August 08, 2013)
- Starting date:
- August 08, 2013
- Posting date:
- August 08, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-35465
Reason
New, more stringent internal testing conducted by Maquet Cardiopulmonary to reduce the possibility of any quality issues in the field has indicated that specific oxygenator lots may not meet product specifications. Specifically, internal testing indicates that the outlet or/and inlet connector port of the unit may dislodge and separate from the main body of the oxygenator. Please note that this recall pertains to specific lots of oxygenators.
Users need to continue to use the reusable mechanical clamp provided by maquet with all remaining Maquet Quadrox oxygenators currently in distribution. The specific lots within this recall may have an increased tendency for separation as indicated in the internal testing results.
Affected products
A. Standard Pump Pack Bioline
Lot or serial number
92084424, 92091970, 92096512, 92098557
Model or catalog number
BEQ-HQV 46900
Companies
- Manufacturer
- Not Applicable
B. Custom Pack with Softline
Lot or serial number
92087670
Model or catalog number
BO-HQV 46901
Companies
- Manufacturer
- Not Applicable
C. Quadrox-I Adult Oxygenator with Integrated Hardshell Reservoir
Lot or serial number
70081881
Model or catalog number
VKMO 70000
Companies
- Manufacturer
- Not Applicable
D. Quadrox-I Adult Oxygenator
Lot or serial number
70082328, 70082790
Model or catalog number
HMO 70000, HMO 71000
Companies
- Manufacturer
- Not Applicable
E. Permanent Life Support Set
Lot or serial number
70075041
Model or catalog number
BE-PLS 2051
Companies
- Manufacturer
- Not Applicable
F. Quadrox Oxygenator with Integrated Hardsteel Reservoir
Lot or serial number
70091907, 92084433, 92087265, 92088079, 92089326
Model or catalog number
HQV 55806, HQV 56103
Companies
- Manufacturer
- Not Applicable
- Date modified: