Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
Summary
The FDA issued a Class I for Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U by B Braun Medical Inc. Reason: Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostati.
Details
Source
Device Recall
External ID
Z-2972-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
Lot/Code Info: UDI-DI (GUDID) - 04046963716752 Serial Numbers 52226, 107529, 123259, 123815, 123843, 139003, 147678, 147721, 147725, 239018, 239165, 239231, 239279, 339337
Quantity Affected: 14
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.
Distribution
US distribution to AL, CA, GA, IL, MI, and TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-07
Company
Breinigsville, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 257 device recalls issued in the same week, part of 403 device-related FDA actions this month.
B Braun Medical Inc has 282 FDA actions in our database, including 269 recalls and 13 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (B Braun Medical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does B Braun Medical Inc have FDA actions?
B Braun Medical Inc has 282 FDA actions in our database, including 269 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2972-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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