Class II

Medical Device Recall: Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362034

B. Braun Medical, Inc. · June 17, 2024

Reason for Recall

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.

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

States Affected

NATIONWIDE

Quantity Affected

280 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2380-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.