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Official recall record

Infusomat® Space Pump IV Set with Anti-Siphon Valve

Health Canada — Medical Devices · 2023-11-17 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2023-11-17
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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