B Braun Medical Inc recalls CARESAFE utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space L…

Recall date

October 29, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0623-2026

FDA classification

Class II

Brand / firm

B Braun Medical Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CARESAFE 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. CARESAFE IV ADMIN SET w/AIRSTOP, 104 IN.; Catalog Number: 354302. 2. CARESAFE ADMIN SET w/15um FILTER, 104 IN; Catalog Number: 354303. 3. CARESAFE IV ADMIN SET w/AIRSTOP, 114 IN.; Catalog Number: 354304. 4. CARESAFE ADMIN SET w/15um FILTER, 114 IN; Catalog Number: 354305. 5. CARESAFE IV ADMIN SET w/AIRSTOP, 110 IN.; Catalog Number: 354306. 6. CARESAFE ADMIN SET w/15um FILTER, 110 IN; Catalog Number: 354307. 7. CARESAFE" IV Administration Set with AirStop Filter, Not made with PVC or DEHP, 2 CARESITE¿ Injection Sites, 2 ULTRAPORT¿ High-FlowFour-Way Stopcocks; CARESAFE ANESTH SET W/AIRSTOP, 134 IN.; Catalog Number: 354308. 8. CARESAFE ANESTH SET w/15um FILTER,134IN.; Catalog Number: 354310.