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

• Reason
• Affected products

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