enFlow Disposable Cartridge (2019-03-14)
- Starting date:
- March 14, 2019
- Posting date:
- March 21, 2019
- 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-69350
Affected Products
enFlow Disposable Cartridge
Reason
Vyaire's decision to initiate this urgent recall notification was based on recently conducted internal testing which has indicated that there is the potential to elute aluminum from the enFlow Disposable Cartridge during intravenous warming therapy with fluid and blood solutions. This global recall is being conducted based on the potetial safety risk associated with aluminium toxicity.
Affected products
enFlow Disposable Cartridge
Lot or serial number
All lots.
Model or catalog number
- 980200EU
- 980202EU
Companies
- Manufacturer
-
Vyaire Medical (Formerly Trading as CareFusion)
22745 Savi Ranch Parkway
Yorba Linda
92887
California
UNITED STATES