FDA-Device2024-07-24Class II
Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490101
B. Braun Medical, Inc.
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.
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
33065 units
Manufactured in
901 Marcon Blvd, Allentown, PA, United States
Products
Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490101
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2398-2024Don't want to check this manually?
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