Reported Dec 3, 2025 · Ongoing
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's…
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?
3 of 3 products
| Model / number | Product as published |
|---|---|
354209. | IV ANES 15DROP W/2 CARESITE ULTRAPORT; Anesthesia IV Set with 2 CARESITE injection sites and high-flow ULTRAPORT stopcock |
490392. | IV ADMIN SET W/60 DROPS/ML 106 IN. |
490428. | IV ADMIN SET W/ 60 DROPS/ML 120 IN. |
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 3542090404696418215004046964182143Primary UDI-DI: 04046964182150; Unit of Dose UDI-DI: 04046964182143. 4903920404696473736704046964737350Primary UDI-DI: 04046964737367; Unit of Dose UDI-DI: 04046964737350. 4904280404696482354104046964823534Primary UDI-DI: 04046964823541; Unit of Dose UDI-DI: 04046964823534. - Amount recalled
- 89,552 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.
Want the full recall guide?
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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