Infusomat recallZ-0124-2024 · B. Braun Medical, Inc. · initiated Sep 21, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from B. Braun Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Component design/selection
What the company is doing
On September 21, 2023, the firm began notifying customers of the issue via "URGENT MEDICAL DEVICE CORRECTION" letters. BBMI will schedule service to update impacted devices. Customers were provided with stickers to identify affected units while waiting for the service to be completed. In the meantime, customers were informed of measures that may aid in continued use of the pumps, such as only using non-impacted devices for the delivery of high-risk medications and placing the impacted units in care areas that do not administer high risk medications. Customers may contact BBMI by calling 1-800-627-7867 (1-800-627-PUMP) for technical support for potential alternate interim measures. ***Updated 8/7/24*** On August 7, 2024, firm identified additional units which were serviced using potentially impacted sensors. Serial numbers were added to the two models already in scope (Article Numbers 8713051U and 8713052U). Serial numbers from an additional model (Article No. 8713050U) also added and tracked under RES 95093.
Recall details
- Recall number
- Z-0124-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 21, 2023
- Posted by the FDA
- Oct 25, 2023
- Recalling firm
- B. Braun Medical, Inc.
- Quantity
- 884
- Product code
- FRN
- FDA submissions
- K142596, K191910
- Distribution
- Domestic distribution nationwide. Foreign distribution to Canada.
Product description
8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Infusomat® 8713052UB. Braun Medical Inc. · Pump, infusion1 recall3 deaths94 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 92978).
- Z-0123-2024 · Open, Classified8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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