FDA Device recall Z-0714-2026
ULTRASITE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pum…
- FDA Device
- Class II
- ongoing
- Published 2025-12-03
On 2025-12-03 the FDA classified a Class II recall of ULTRASITE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pum… by B Braun Medical, citing potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0714-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-29 |
| Published | 2025-12-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | B Braun Medical |
| Distribution | n/a |
Product
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
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Identifiers
| code_info | 1. Catalog Number: 352049-C; Primary UDI-DI: 04046964717666; Unit of Dose UDI-DI: 04046964717659; Expiration Date: Earl…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0714-2026%22
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