FDA recall Z-0640-2026

B Braun Medical Inc · Class II · device

Product

Infusomat 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. UNIV.15DROP PUMP SET W/3 SAFELINE LL; 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; Catalog Number: 362032. 2. UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; Catalog Number: 362033. 3. 60DROP METRISET PUMP SET, 3 SAFELINE; Priming volume: 19mL, length: 120in, SafeLine; Catalog Number: 362034. 4. Y TYPE BLOOD PUMP SET, SAFELINE INJ; Priming volume: 39mL, length: 120in, SafeLine¿; Catalog Number: 362043. 5. UNIV. 15 DROP PUMP SET W/ 0.2 FILTER; 15 drops/mL, priming volume: 26mL, length: 124in, SafeLine; Catalog Number: 362050. 6. SPACE PUMP SET 15 DROP W/2 SAFEDAY; SPACE PUMP SET 15 DROP W/2 SAFEDAY; Catalog Number: 362420. 7. UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL; 15 drops/mL, pri

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-10-29
Report date
2025-12-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bethlehem, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0640-2026