Reported Dec 3, 2025 · Ongoing
ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space…
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 · 824 12th Ave · Bethlehem, PA · 18018-3524
Is this the product you have?
4 of 4 products
| Model / number | Product as published |
|---|---|
V1443. | Primary Gravity IV Set, 2 Non-Needle-Free Injection Sites |
V1447. | ADDITIVE SET W/ 3 INJ SITES -DR* |
V1448. | ADD PEDIATRIC 3 INJ LUER LOCK |
V1484. | ADULT ADD 2 INJ CKV LUER LOCK |
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Barcodes Product as published V14430404696418835004046964188343Primary UDI-DI: 04046964188350; Unit of Use UDI-DI: 04046964188343. V14470404696418841104046964188404Primary UDI-DI: 04046964188411; Unit of Use UDI-DI: 04046964188404. V14480404696418843504046964188428Primary UDI-DI: 04046964188435; Unit of Use UDI-DI: 04046964188428. V14840404696418847304046964188466Primary UDI-DI: 04046964188473; Unit of Use UDI-DI: 04046964188466. - Amount recalled
- 43,900 units
This recall covers 116 products
The agency filed one notice per product. You are reading one of them; the other 115 are below.
103 more are in the archive.
Why it was recalled
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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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