Device product
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 SET 3 CARESITE ULTRA ZERO 2/SWAB SAFE; IV Set With 3 CARESITE Injection Sites, ULTRAPORT Zer0 High-Flow, 4-Way Stopcock, and Dual Port SAFEPORT; Catalog Number: 457515.
Z-0651-2026
Product summary
- Event
- Event 97816
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 135,000 units
- Official record key
device-enforcement:Z-0651-2026
Official wording
Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Code information: 1. Catalog Number: 457515; Primary UDI-DI: 04046964716188; Unit of Dose UDI-DI:04046964716171.
Distribution pattern: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Derived failure modes
-
Unknown
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).