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FDAJune 25, 2021device

Infusomat Space Volumetric Pump Administration Set, Product Code 490100

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump.

What to do

FDA enforcement status: Terminated

Brands named

b braun medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Infusomat Space Volumetric Pump Administration Set, Product Code 490100 — Recall Details · AllClear