Z-0124-2024Class I

8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System

Name: Z-0124-2024 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
Creator: B. Braun Medical, Inc.
Published: 2023-09-21
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2023-09-21 / Open, Classified / root cause: design

FDA source

B. Braun Medical, Inc. began a recall of 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System on 2023-09-21. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0124-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-09-21
Posted: 2023-10-25
Recalling firm: B Braun Medical Inc
Product: 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
Product code: FRN Pump, Infusion
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Quantity in commerce: 884
Distribution: Domestic distribution nationwide. Foreign distribution to Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0124-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0123-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-25
Z-0124-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-25

Product code FRN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)