Reported Dec 3, 2025 · Ongoing
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat…
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 |
|---|---|
490448. | EXTENSION SET, 18 IN |
490465. | EXTENSION SET, 52 IN. |
490486. | EXTENSION SET 49 IN. |
490577. | EXTENSION SET, 12 CARESTITE LADS |
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Barcodes Product as published 4904480404696484885804046964848841Primary UDI-DI: 04046964848858; Unit of Dose UDI-DI: 04046964848841. Shelf Life: Earliest Exp of Comp or 36mths. 4904650404696495073504046964950728Primary UDI-DI: 04046964950735; Unit of Dose UDI-DI: 04046964950728. Shelf Life: Earliest Exp of Comp or 36mths. 4904860404696499125704046964991240Primary UDI-DI: 04046964991257; Unit of Dose UDI-DI: 04046964991240. Shelf Life: Earliest Exp of Comp or 24mths. 4905770404695528753604046955287529Primary UDI-DI: 04046955287536; Unit of Dose UDI-DI: 04046955287529. Shelf Life: Earliest Exp of Comp or 36mths. - Amount recalled
- 43,452 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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