FDA Device recall Z-0124-2024
8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK
- FDA Device
- Class I
- ongoing
- Published 2023-11-01
On 2023-11-01 the FDA classified a Class I recall of 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK 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-0124-2024 |
| 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
8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; 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: 04046964708626 Serial Numbers: 878498 -881897 ***Update 8/7/24*** Additional SNs 133238, 133975, 490442, 54681…UDI-DI: 04046964708626 Serial Numbers: 878498 -881897 ***Update 8/7/24*** Additional SNs 133238, 133975, 490442, 546815, 559325, 561645, 562713, 593049, 617405, 617409, 618522, 783680, 810031 |
|---|
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-0124-2024%22
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