FDAFDA · Food and drugs·Recall number Z-2381-2024
Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362050
Published July 24, 2024 · Recall initiated: June 17, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- B. Braun Medical, Inc.
- Distributor
- Worldwide distribution - US Nationwide and the country of Canada.
- Lot
- UDI-DI 04046964182655; All Lots Distributed After 08AUG2023.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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