RegWardenFDA facility compliance records
Recall

Class I — B Braun Medical Inc

Recalling firmB. BRAUN MEDICAL SAS
Registered facilityB. BRAUN MEDICAL (the firm's only registered facility)
ClassificationClass I
StatusOngoing
ReasonExtension 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.
ProductInfusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
Quantity14
DistributionUS distribution to AL, CA, GA, IL, MI, and TX.
Initiated2024-08-07
Classified2024-09-06
Recall numberZ-2972-2024
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class I recall — B Braun Medical Inc (Z-2972-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95093/

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