Product Wiki · Recalls · Health Canada — Medical Devices

ADULT AND PEDIATRIC OXYGENATOR BRACKETS (2016-06-16) — recall 55167

Health Canada — Medical Devices · Canada · 2016-06-30 · 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
55167
Date of alert
2016-06-30
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: In order to further mitigate the potential risk of infection by non-Tuberculous mycobacteria (see Health Canada RA-54106), Sorin (now Livanova) is replacing certain oxygenator mounting brackets that are currently being used with the heater-cooler 3T, as they could be a source of re-contamination with non-Tuberculous mycobacteria of a clean heater cooler 3T's water circuit.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/adult-and-pediatric-oxygenator

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.