Z-0659-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 3, 2025
- Initiation Date
- October 29, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 129,480 units
Product 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 60 DROP/ML, 105 IN.; Catalog Number: 490242. 2. IV ADMN SET W/15 DROP,2 CARESITE,142 IN.; Catalog Number: 490311. 3. IV ADMIN SET W/15 DROPS/ML 115 in.; Catalog Number: 490353.
Reason for Recall
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Distribution Pattern
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Code Information
1. Catalog Number: 490242; Primary UDI-DI: 04046964716461; Unit of Dose UDI-DI: 04046964716454. 2. Catalog Number: 490311; Primary UDI-DI: 04046964539688; Unit of Dose UDI-DI: 04046964525629. 3. Catalog Number: 490353; Primary UDI-DI: 04046964602368; Unit of Dose UDI-DI: 04046964602351.