Reported Jul 24, 2024 · Ongoing
Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-powered infusion pump for intravenous (IV)…
B. Braun Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: B. Braun Medical, Inc. · 901 Marcon Blvd · Allentown, PA · 18109-9512
Is this the product you have?
- Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
- Model/Catalog Number362033
- Lot codes and dates
UDI-DI 04046964837821All Lots Distributed After 01AUG2023
- Amount recalled
- 47370 units
This recall covers 29 products
The agency filed one notice per product. You are reading one of them; the other 28 are below.
16 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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 product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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