Z-0669-2026 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
- 190,625 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 15 DROP W/ CARESITE EXT SET; Catalog Number: 490528. 2. 111 IN. IV ADMIN SET W/ 12 IN. Y-EXT SET; Catalog Number: 490550. 3. IV ADMIN SET, 125 IN. w/ EXT SET 9 IN.; Catalog Number: 490605. 4. IV SET 15 DR 3CARESITE 2 ULTRAPORT; Catalog Number: 490616. 5. IV ADMIN SET, 2 CARSITE LADS; Catalog Number: 490654.
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: 490528; Primary UDI-DI: 04046955203284; Unit of Dose UDI-DI: 04046955203277; Expiration Date: Earliest Exp of Comp or 36mths. 2. Catalog Number: 490550; Primary UDI-DI: 04046955270347; Unit of Dose UDI-DI: 04046955270330; Expiration Date: Earliest Exp of Comp or 24mths. 3. Catalog Number: 490605; Primary UDI-DI: 04046955352876; Unit of Dose UDI-DI: 04046955352869; Expiration Date: Earliest Exp of Comp or 36mths. 4. Catalog Number: 490616; Primary UDI-DI: 04046955664696; Unit of Dose UDI-DI: 04046955664689; Expiration Date: Earliest Exp of Comp or 36mths. 5. Catalog Number: 490654; Primary UDI-DI: 04046955836369; Unit of Dose UDI-DI: 04046955836352; Expiration Date: Earliest Exp of Comp or 36mths.