Product Wiki · Recalls · Health Canada — Medical Devices

Alaris Pump Module Model 8100 (2017-06-12) — recall 57277

Health Canada — Medical Devices · Canada · 2017-09-26 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
57277
Date of alert
2017-09-26
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: The separation of one or more posts that connect the mechanism frame to the bezel assembly may prevent the device from delivering an accurate amount of fluid flow through the pumping cycle resulting in an over or under infusion condition. In addition, it may prevent the pump from alarming for an upstream or downstream occlusion condition. The separation of one or more posts are not visible to the end user. An over or under infusion may lead to injuries requiring medical intervention.
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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