Product Wiki · Recalls · Health Canada — Medical Devices

Alaris Pump Module Model 8100 (2018-04-10) — recall 60905

Health Canada — Medical Devices · Canada · 2018-05-04 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
60905
Date of alert
2018-05-04
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: The component of the Alaris pump module mechanical assembly of concern is the bezel assembly, specifically the bezel posts. The affected mechanical assembly may have separation of one or more of the 6 posts that connect the mechanism frame to the bezel assembly. This can result in under or over infusion to the patient. The affected bezel assembly was manufactured between September and December 2011.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/alaris-pump-module-model-8100-

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.

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