Z-0714-2026 Class II Ongoing
FDA device recall Z-0714-2026 was initiated by B Braun Medical Inc on October 29, 2025 and is designated Class II. Reason for recall: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). The recall status is ongoing. Affected quantity: 41,400 units.
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
- 41,400 units
Product Description
ULTRASITE 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/ 2 ULTRASITE VLV, 104 IN; Catalog Number: 352049-C. 2. IV ADMIN SET W/ 3 ULTRASITE VLV, 112 IN; Catalog Number: 375100-C.
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: 352049-C; Primary UDI-DI: 04046964717666; Unit of Dose UDI-DI: 04046964717659; Expiration Date: Earliest Exp of Comp or 60mths. 2. Catalog Number: 375100-C; Primary UDI-DI: 04046964717680; Unit of Dose UDI-DI: 04046964717673; Expiration Date: Earliest Exp of Comp or 60mths.