8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
Reported: November 1, 2023 Initiated: September 21, 2023 #Z-0124-2024
Product Description
8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; 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.
Details
- Recalling Firm
- B. Braun Medical, Inc.
- Units Affected
- 884
- Distribution
- Domestic distribution nationwide. Foreign distribution to Canada.
- Location
- Allentown, PA
Frequently Asked Questions
What product was recalled? ▼
8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System. Recalled by B. Braun Medical, Inc.. Units affected: 884.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 1, 2023. Severity: Critical. Recall number: Z-0124-2024.
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