FDAClass ISeptember 18, 2024

Infusomat Space Infusion System/ Large Volume Pump recall

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

Why was Infusomat Space Infusion System/ Large Volume Pump 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI (GUDID) - 04046963716752 Serial Numbers 52226, 107529, 123259, 123815, 123843, 139003, 147678, 147721, 147725, 239018, 239165, 239231, 239279, 339337

Product
Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
Recalling firm
B Braun Medical Inc
Quantity
14
Distribution
US distribution to AL, CA, GA, IL, MI, and TX.
Recall date
September 18, 2024
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls