FDA recall Z-2402-2024

B. Braun Medical, Inc. · Class II · device

Product

Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490361

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.

Key facts

Status
Ongoing
Initiation date
2024-06-17
Report date
2024-07-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2402-2024