Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0123-2024 — 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System

U.S. FDA — Device Enforcement · United States · 2023-09-21 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0123-2024
Date of alert
2023-09-21
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
B. Braun Medical, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04046964660887
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.