Class I — B. Braun Medical, Inc.
| Recalling firm | B. BRAUN MEDICAL INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| 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. |
| Product | 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System |
| Quantity | 9771 |
| Distribution | Domestic distribution nationwide. Foreign distribution to Canada. |
| Initiated | 2023-09-21 |
| Classified | 2023-10-25 |
| Recall number | Z-0123-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — B. Braun Medical, Inc. (Z-0123-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92978/
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