FDA Enforcement
Class II
Ongoing
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/CARESITE EXT SET; Catalog Number: 490400.
Recall: Z-0663-2026
·
Reported December 3, 2025
Enforcement
- Recall Number
- Z-0663-2026
- 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/CARESITE EXT SET; Catalog Number: 490400.
Reason
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Code Info
1. Catalog Number: 490400; Primary UDI-DI: 04046964761393; Unit of Dose UDI-DI: 04046964761386.
Distribution
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Quantity
19,104 units