Health Canada — Medical Devices · Canada · 2019-04-09 · Type I
🏛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 →
Reported risk: Several cases have come to Draeger's attention in which cracks have formed in the breathing hose during ventilation. If a crack forms in the breathing hose during operation, a leak will result that can negatively affect ventilation of the patient. If the breathing circuit is used with devices listed as compatible in the Instructions for Use, any leakages will be detected and the device will give an alarm.
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.
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.