FDAClass IIOctober 30, 2024

SynchroMed II Infusion Pump. Product Number: 8637-20 recall

SynchroMed II Infusion Pump. Product Number: 8637-20

Why was SynchroMed II Infusion Pump. Product Number: 8637-20 recalled?

Potential for error and inability to interrogate pump due to data corruption in the pump memory.

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?

GTIN Number: 00643169630505. Serial Number: NGP004814H

Product
SynchroMed II Infusion Pump. Product Number: 8637-20
Recalling firm
Medtronic Neuromodulation
Quantity
1 unit
Distribution
US Nationwide distribution in the state of Mississippi.
Recall date
October 30, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls