Z-2972-2024Class I

Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U

Name: Z-2972-2024 Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
Creator: B Braun Medical Inc
Published: 2024-08-07
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2024-08-07 / Open, Classified / root cause: design

FDA source

B Braun Medical Inc began a recall of Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U on 2024-08-07. FDA classified it as Class I and gives the reason as "Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream...". 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-2972-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-08-07
Posted: 2024-09-07
Recalling firm: B Braun Medical Inc
Product: Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
Product code: FRN Pump, Infusion
Reason for recall: Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream occlusion alarms. Additional devices have been affected.
Root cause tag: design
FDA root cause: Component design/selection
Action: On August 7, 2024, the firm notified customers via "URGENT MEDICAL DEVICE CORRECTION" letters which specified that previous recall RES 92978 had been extended to include additional serial numbers as well as one additional model number. The updated serial numbers for the prior models has been documented under RES 92978. This present record documents the addition of model number 8713050U. Customers were instructed to identify affected units in their facilities and to place the provided stickers on impacted units to aid clinical and biomedical staff in identifying units which require sensor exchange and application of interim control measures described in the letter. The firm recommends that consignees use non-impacted devices for the delivery of high-risk medications, and do not use impacted serial numbers for high-risk medications until the upstream occlusion sensor can be replaced. Return the product correction acknowledgement for to B.Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to [email protected] even if the total inventory in your possession is zero (0). A Field Service Representative will contact customers to arrange for a time and date to check their pump and replace their impacted sensors. If you have any questions, contact us at 610-266-0500.
Quantity in commerce: 14
Distribution: US distribution to AL, CA, GA, IL, MI, and TX.
Product codes and lots: UDI-DI (GUDID) - 04046963716752 Serial Numbers 52226, 107529, 123259, 123815, 123843, 139003, 147678, 147721, 147725, 239018, 239165, 239231, 239279, 339337

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2972-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2972-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-06

Product code FRN

K191910Class IISpaceStation MRIB. Braun Melsugen AG / cleared 2020-03-12

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)