Product Wiki · Recalls · Health Canada — Medical Devices

Sapphire Epidural Set Yellow-Striped Microbore (2018-11-04) — recall 58877

Health Canada — Medical Devices · Canada · 2018-11-28 · 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
58877
Date of alert
2018-11-28
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: ICU Medical has identified an issue with the yellow striped sapphire epidural set. It was identified that the inclusion of both a 0.2 micron filter and a Pressure Activated Valve (PAV) with the filter in a proximal location can increase the probability of distal occlusions alarms. This configuration is limited to this sapphire epidural set.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/sapphire-epidural-set-yellow-s

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.