8713051U — Class I medical device recall Z-0123-2024
Ongoing recall by B. Braun Medical, Inc., reported 2023-11-01, distributed nationwide. Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to
| Recall number | Z-0123-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical, Inc., Allentown, PA, United States |
| Recall initiated | 2023-09-21 |
| Classified | 2023-10-25 |
| Reported by FDA | 2023-11-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 9,771 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04046964660887 |
| Serial numbers | 868497, 892669 |
Product
8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0123-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.