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Medtronic Affinity Fusion Oxygenators (2017-01-11)
- Starting date:
- January 11, 2017
- Posting date:
- January 17, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-61826
Affected Products
- Custom Pack W/Bb Coating
- Affinity Fusion Oxygenator - Oxygenator with Integrated Arterial Filter and Balance Biosurface
- Affinity Fusion Oxygenator - Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface
Reason
Medtronic has identified an out-of-specification condition exhibiting additional plastic (flash) in the arterial sampling port adjacent to the arterial outlet port of the oxygenator. Medtronic testing has not conclusively ruled out a potential impact of the flash, therefore manufacturer is recalling the specific lots.
Affected products
A. Custom Pack W/Bb Coating
Lot or serial number
211991385
Model or catalog number
BB9G59R5
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES
B. Affinity Fusion Oxygenator - Oxygenator with Integrated Arterial Filter and Balance Biosurface
Lot or serial number
13186543
Model or catalog number
BB811
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES
C. Affinity Fusion Oxygenator - Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
BB841
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES