Severity
Critical
CriticalClass IOngoing
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 FDA Devices action (record #Z-2972-2024) was formally reported on September 18, 2024, with the manufacturer initiating the action on August 7, 2024. It is classified under Critical severity (Class I), with a current status of Ongoing. B Braun Medical Inc is listed as the recalling firm, operating out of Breinigsville, PA. Federal records list the affected scope as 14.
The documented reason for this recall is: 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 oc… Distribution data in the federal record shows the product reached: US distribution to AL, CA, GA, IL, MI, and TX.. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
14
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U. Recalled by B Braun Medical Inc. Units affected: 14.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2024. Severity: Critical. Recall number: Z-2972-2024.
Where was the recalled product distributed? ▼
Distribution: US distribution to AL, CA, GA, IL, MI, and TX..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2972-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 18, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.