FDA Devices recall · Reported September 18, 2024
Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
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 tri…
B Braun Medical Inc recalled Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U - a critical-severity action.
Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U was recalled by B Braun Medical Inc in September 18, 2024. Reason: Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease prope…. Check the official notice for the remedy. Verify recall #Z-2972-2024 with the FDA Devices before acting.
The recall
B Braun Medical Inc issued this critical-severity FDA Devices recall-Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease prope….
- Critical
- severity level
- 14 units
- affected scope
- Class I
- classification
- September 18, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2972-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-2972-2024 |
| Date reported | September 18, 2024 |
| Date initiated | August 7, 2024 |
| Recalling firm | B Braun Medical Inc |
| Firm location | Breinigsville, PA |
| Affected scope | 14 |
| Distribution | US distribution to AL, CA, GA, IL, MI, and TX. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2972-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026