Z-0123-2024 Class I Ongoing
FDA device recall Z-0123-2024 was initiated by B. Braun Medical, Inc. on September 21, 2023 and is designated Class I. 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 medic… The recall status is ongoing. Affected quantity: 9771.
Recall Details
- Product Type
- Devices
- Report Date
- November 1, 2023
- Initiation Date
- September 21, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9771
Product Description
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.
Distribution Pattern
Domestic distribution nationwide. Foreign distribution to Canada.
Code Information
UDI-DI: 04046964660887 Serial Numbers: 868497 -892669 ***Updated 8/7/24*** SNs added: 430056, 430119, 430155, 430243, 551518, 685947, 703196, 705968, 726936, 737729, 753364, 774163, 790843, 814074