FDA Device recall Z-0618-2026
Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large…
- FDA Device
- Class II
- ongoing
- Published 2025-12-03
On 2025-12-03 the FDA classified a Class II recall of Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large… 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-0618-2026 |
| 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
Blood 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. Y-TYPE BLOOD SET, 3 CARSITE LADS, 146 IN; Catalog Number: 490530.
Reason
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Identifiers
| code_info | Catalog Number: 490530; Primary UDI-DI: 04046955203321; Unit of Dose UDI-DI: 04046955203314. |
|---|
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-0618-2026%22
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