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FDAJune 17, 2024device

Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490103

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

The hazard

Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

What to do

FDA enforcement status: Ongoing

Brands named

b braun medical

UPCs

04046964302107

Recall history

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

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Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490103 — Recall Details · AllClear