FDAClass IApril 30, 2014

SIGMA SPECTRUM Volumetric Infusion Pump with Master recall

SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are…

Why was SIGMA SPECTRUM Volumetric Infusion Pump with Master recalled?

Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated System Error 322 occurrences.

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?

Product Codes: 35700BAX, 35700ABB

Product
SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are…
Recalling firm
Baxter Healthcare Corp.
Quantity
277,096 units (revised)
Distribution
Worldwide Distribution - USA Nationwide including PR and the country of Canada.
Recall date
April 30, 2014
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls