Trillium Affinity and Affinity NT Cardiotomy/Venous Reservoir (CVR) (2018-01-16)
- Starting date:
- January 16, 2018
- Posting date:
- February 9, 2018
- 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-65926
Affected products
- AFFINITY NT CARDIOTOMY/VENOUS RESERVOIR (CVR)
- TRILLIUM AFFINITY NT CARDIOTOMY/VENOUS RESERVOIR
Reason
During internal testing, Medtronic identified the potential for a sterile barrier breach in the pouch. Other packaging configurations are not affected by this issue.
Affected products
A. AFFINITY NT CARDIOTOMY/VENOUS RESERVOIR (CVR)
Lot or serial number
All Unexpired Lots
Model or catalog number
540
61399409462
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
B. TRILLIUM AFFINITY NT CARDIOTOMY/VENOUS RESERVOIR
Lot or serial number
All Unexpired Lots
Model or catalog number
540T
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES