CLASS IIONGOINGDevice recall · Reported 3 Dec 2025 · FDA Enforcement Report
Ultrasite set utilized in gravity IV administration sets recalled
B Braun Medical is recalling Ultrasite set utilized in gravity IV administration sets and pump administration sets. The recall was initiated on 29 Oct 2025 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codes1. Catalog Number: 352049-C; Primary UDI-DI: 04046964717666; Unit of Dose UDI-DI: 04046964717659; Expiration Date: Earliest Exp of Comp or 60mths. 2. Catalog Number: 375100-C; Primary UDI-DI: 04046964717680; Unit of Dose UDI-DI: 04046964717673; Expiration Date: Earliest Exp of Comp or 60mths.
Quantity recalled41,400 units
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Product as listed by the FDA
ULTRASITE 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 ADMIN SET W/ 2 ULTRASITE VLV, 104 IN; Catalog Number: 352049-C. 2. IV ADMIN SET W/ 3 ULTRASITE VLV, 112 IN; Catalog Number: 375100-C.
Where it was distributed
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Questions about this recall
Why was it recalled?
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Which lots are affected?
1. Catalog Number: 352049-C; Primary UDI-DI: 04046964717666; Unit of Dose UDI-DI: 04046964717659; Expiration Date: Earliest Exp of Comp or 60mths. 2. Catalog Number: 375100-C; Primary UDI-DI: 04046964717680; Unit of Dose UDI-DI: 04046964717673; Expiration Date: Earliest Exp of Comp or 60mths.
Where was it sold?
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.