B Braun Medical Inc recalls Caresite utilized in gravity IV administration sets and pump administration sets utilized

Recalling company

B Braun Medical Inc

Product

Caresite 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 numbers: 1. Primary Gravity IV Set with 2 CARESITE¿ Injection Sites; IV ADMIN SET 60 DROP W/2 CARESITE; Catalog Number: 354204. 2. Primary Gravity IV Set with 3 CARESITE¿ Injection Sites; IV ADMIN SET 15 DROP W/3 CARESITE; Catalog Number: 354205. 3. Primary Gravity IV Set with 3 CARESITE¿ Injection Sites; IV ADMIN SET 60 DROP W/3 CARESITE; Catalog Number: 354206.

Reason

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Oct 29, 2025

Reported

Dec 3, 2025

Distribution

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

Status

Ongoing

Quantity

12,225,913 units

Lot / codes

1. Catalog Number: 354204; Primary UDI-DI: 04046964182075; Unit of Dose UDI-DI: 04046964182068. 2. Catalog Number: 354205; Primary UDI-DI: 04046964182099; Unit of Dose UDI-DI: 04046964182082. 3. Catalog Number: 354206; Primary UDI-DI: 04046964182112; Unit of Dose UDI-DI: 04046964182105.

Company location

Bethlehem, PA

Recall type

Voluntary: Firm initiated

Recall number

Z-0624-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0624-2026 in the FDA Enforcement Report. Also see FDA recall press releases.