Product Wiki · Recalls · Health Canada — Medical Devices

enFlow Disposable Cartridge (2019-03-14) — recall 59470

Health Canada — Medical Devices · Canada · 2019-03-21 · Type II

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
59470
Date of alert
2019-03-21
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/enflow-disposable-cartridge-20

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.