Data Foundry

Medical device recalls 2024

Infusomat Space Infusion System/ Large Volume Pump — Class I medical device recall Z-2972-2024

Ongoing recall by B Braun Medical Inc, reported 2024-09-18, distributed in AL, CA, GA, IL, MI, TX. Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper

Recall numberZ-2972-2024
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmB Braun Medical Inc, Breinigsville, PA, United States
Recall initiated2024-08-07
Classified2024-09-06
Reported by FDA2024-09-18
DistributedAL, CA, GA, IL, MI, TX
Quantity14
Reason classesdevice malfunction
UPC / GTIN / UDI-DI04046963716752
Serial numbers107529, 123259, 123815, 123843, 139003, 147678, 147721, 147725, 239018, 239165, 239231, 239279, 339337, 52226

Product

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2972-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.