Product Wiki · Recalls · Health Canada — Medical Devices

Fast-Cath Hemostasis Introducer (2019-12-09) — recall 63050

Health Canada — Medical Devices · Canada · 2020-01-10 · Type III

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
63050
Date of alert
2020-01-10
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Abbott is voluntarily recalling three lots of Abbott Fast-Cath Hemostasis Introducer (model 406143, lot numbers 6917183, 6950628, and 7099144). As a result of a manufacturing error, these three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/fast-cath-hemostasis-introduce

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.