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B Braun Medical Inc recalls Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space La
Recalled December 3, 2025 · FDA recall Z-0624-2026 · B Braun Medical
Hazard
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). · FDA Class II
Units
12,225,913 units
Sold at
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Description
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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.
Manufacturer(s)
B Braun Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →