FDAClass IIDecember 7, 2016

Baxter SIGMA Spectrum INFUSION PUMP with Master Drug recall

Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Code 35700BAX2, Unique Device Identifier GTIN…

Why was Baxter SIGMA Spectrum INFUSION PUMP with Master Drug recalled?

A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Contact CDRH for list of affected serial numbers (15,517).

Product
Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Code 35700BAX2, Unique Device Identifier GTIN…
Recalling firm
Baxter Healthcare Corp.
Quantity
15,517 units (US: 9560; Canada: 5957)
Distribution
Nationwide Distribution, Puerto Rico and Canada
Recall date
December 7, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls