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, 15 DR/ML,2 CARESITE,146 IN; Catalog Number: 490315. 2. IV ADMN SET,2 CARESITE, SAFEPORT,129 IN.; Catalog Number: 490331. 3. IV ADMIN SET 15 DROPS/ML, CARESITE,98 IN; Catalog Number: 490376.
Enforcement
- Recall Number
- Z-0664-2026
- 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, 15 DR/ML,2 CARESITE,146 IN; Catalog Number: 490315. 2. IV ADMN SET,2 CARESITE, SAFEPORT,129 IN.; Catalog Number: 490331. 3. IV ADMIN SET 15 DROPS/ML, CARESITE,98 IN; Catalog Number: 490376.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
1. Catalog Number: 490315; Primary UDI-DI: 04046964527173; Unit of Dose UDI-DI: 04046964525612. 2.Catalog Number: 490331; Primary UDI-DI: 04046964541148; Unit of Dose UDI-DI: 04046964541131. 3. Catalog Number: 490376; Primary UDI-DI: 04046964718182; Unit of Dose UDI-DI: 04046964718175.
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
11,832 units