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[Recalled] OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490564 — Potential for the backcheck valve to malfunction, resul

recall fda device united-states

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

ProductOUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490564
Brand / manufacturerB. Braun Medical, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2404-2024
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date17 June 2024
EAN / barcode04046955275588

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from B. Braun Medical, Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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