Reported Dec 3, 2025 · Ongoing
Caresite 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?
3 of 3 products
| Model / number | Product as published |
|---|---|
354204. | Primary Gravity IV Set with 2 CARESITE¿ Injection Sites; IV ADMIN SET 60 DROP W/2 CARESITE |
354205. | Primary Gravity IV Set with 3 CARESITE¿ Injection Sites; IV ADMIN SET 15 DROP W/3 CARESITE |
354206. | Primary Gravity IV Set with 3 CARESITE¿ Injection Sites; IV ADMIN SET 60 DROP W/3 CARESITE |
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 3542040404696418207504046964182068Primary UDI-DI: 04046964182075; Unit of Dose UDI-DI: 04046964182068. 3542050404696418209904046964182082Primary UDI-DI: 04046964182099; Unit of Dose UDI-DI: 04046964182082. 3542060404696418211204046964182105Primary UDI-DI: 04046964182112; Unit of Dose UDI-DI: 04046964182105. - Amount recalled
- 12,225,913 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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