FDA Device recall Z-0123-2024
8713051U, Infusomat Large Volume Pump, Wireless
- FDA Device
- Class I
- ongoing
- Published 2023-11-01
On 2023-11-01 the FDA classified a Class I recall of 8713051U, Infusomat Large Volume Pump, Wireless by B Braun Medical, citing upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instab….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0123-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-09-21 |
| Published | 2023-11-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
Reason
Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions. In some cases, this may be life-threatening or may lead to death.
Identifiers
| code_info | UDI-DI: 04046964660887 Serial Numbers: 868497 -892669 ***Updated 8/7/24*** SNs added: 430056, 430119, 430155, 430243,…UDI-DI: 04046964660887 Serial Numbers: 868497 -892669 ***Updated 8/7/24*** SNs added: 430056, 430119, 430155, 430243, 551518, 685947, 703196, 705968, 726936, 737729, 753364, 774163, 790843, 814074 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0123-2024%22
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