FDA Enforcement
Class I
Ongoing
8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
Recall: Z-0124-2024
·
Reported November 1, 2023
Enforcement
- Recall Number
- Z-0124-2024
- Event ID
- 92978
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- B. Braun Medical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 1, 2023
- Initiation Date
- September 21, 2023
- Classification Date
- October 25, 2023
- Address
- 901 Marcon Blvd, N/A, Allentown, PA, 18109-9512, United States
Description
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.
Code Info
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
Distribution
Domestic distribution nationwide. Foreign distribution to Canada.
Quantity
884