Product Wiki · Recalls · Health Canada — Medical Devices

Infusomat® Space Pump IV Set with Anti-Siphon Valve — recall 74606

Health Canada — Medical Devices · Canada · 2023-11-17 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
74606
Date of alert
2023-11-17
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
General hospital and personal use
Product type
Medical devices
Reported risk: In the identified lot number range of administration sets, the tubing outer diameter may vary in size. Additionally, the length of the tubing which contacts the air sensor may be too short resulting in the need to stretch the tubing to properly fit within the Infusomat® space pump. If the tubing is stretched or the tubing outer diameter is too small, this may result in suboptimal coupling between the administration set and the air-in-line sensor dampening the signal of the air-in-line sensor. If the signal is dampened, the Infusomat® space pump may generate false air-in-line alarms. Recall start date: October 23, 2023
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/infusomatr-space-pump-iv-set-a

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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