Z-0713-2026 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
- 46,250 units
Product Description
SAFELINE 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. UNIVERSAL IV ADMIN SET; Catalog Number: 352604. 2. SAFELINE ADDITIV ALTVTD 3 INJ S; Primary Gravity IV Set with 3 SafeLine Injection Sites; Catalog Number: NF1251. 3. SAFELINE PED. ADDITIVE; Primary Gravity IV Set with 3 SafeLine Injection Sites; Catalog Number: NF1290.
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: 352604; Primary UDI-DI: 04046964181870; Unit of Dose UDI-DI: 04046964181863; Expiration Date: Earliest Exp of Comp or 60mths. 2. Catalog Number: NF1251; Primary UDI-DI: 04046964187100; Unit of Dose UDI-DI: 04046964187094; Expiration Date: Earliest Exp of Comp or 60mths. 3. Catalog Number: NF1290; Primary UDI-DI: 04046964187148; Unit of Dose UDI-DI: 04046964187131; Expiration Date: Earliest Exp of Comp or 60mths.