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Health product recall

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

  1. Custom Pack W/Bb Coating
  2. Affinity Fusion Oxygenator - Oxygenator with Integrated Arterial Filter and Balance Biosurface
  3. 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