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?
4 of 4 products
| Model / number | Product as published |
|---|---|
| — | IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ANES 15DROP W/2 CARESITE 2 ULTRAPORT |
| — | Anesthesia IV Set with 2 CARESITE injection sites and two high-flow ULTRAPORT stopcocks |
354210. | 2. IV ADMIN SET 15 DR/ML, 2 B/C VLV, 97IN. |
490389. | — |
- Lot codes and dates
7 of 7 products
Products covered by this recall Model / number Barcodes Product as published 354210— — 04046964182174Primary UDI-DI: 04046964182174 — 04046964182167Unit of Dose UDI-DI: 04046964182167 490389Expiration Date: Earliest Exp of Comp or 36mths. 2. — 04046964730207Primary UDI-DI: 04046964730207 — 04046964730191Unit of Dose UDI-DI: 04046964730191 — Expiration Date: Earliest Exp of Comp or 24mths. - Amount recalled
- 1,861,111 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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