IV Administration 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/15 DROPS/ML, 126 IN.; Catalog Number: 490488. 2. IV ADMIN SET W/15 DROPS/ML, 132 IN.; Catalog Number: 490492. 3. IV ADMIN SET W/15 DROPS/ML, 139 IN.; Catalog Number: 490503.
Enforcement
- Recall Number
- Z-0682-2026
- Event ID
- 97816
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- B Braun Medical Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 3, 2025
- Initiation Date
- October 29, 2025
- Classification Date
- November 26, 2025
- Address
- 824 12th Ave, N/A, Bethlehem, PA, 18018-3524, United States
Description
IV Administration 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/15 DROPS/ML, 126 IN.; Catalog Number: 490488. 2. IV ADMIN SET W/15 DROPS/ML, 132 IN.; Catalog Number: 490492. 3. IV ADMIN SET W/15 DROPS/ML, 139 IN.; Catalog Number: 490503.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
1. Catalog Number: 490488; Primary UDI-DI: 04046955086870; Unit of Dose UDI-DI: 04046955086863; Expiration Date: Earliest Exp of Comp or 24mths. 2. Catalog Number: 490492; Primary UDI-DI: 04046955086757; Unit of Dose UDI-DI: 04046955086740; Expiration Date: Earliest Exp of Comp or 36mths. 3. Catalog Number: 490503; Primary UDI-DI: 04046955135714; Unit of Dose UDI-DI: 04046955135707; Expiration Date: Earliest Exp of Comp or 36mths.
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
187,464 units