FDAClass IISeptember 9, 2020

BD Alaris System. The EtCO2 module is a capnograph recall

BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional…

Why was BD Alaris System. The EtCO2 module is a capnograph recalled?

Infusion pump component defect may result in interruption of patient monitoring

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?

Model: EtCO2 8300; Lot/Serial numbers: 10002682711, 10002720508, 1000287042, 10002882569

Product
BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional…
Recalling firm
CareFusion 303, Inc.
Quantity
680 units
Distribution
U.S. Nationwide distribution including in the states of AZ, CA, FL, GA, IA, ID, IL, KS, LA, MI, MN, MO, MS, MT, NC, NE, NV, NY, OH, PA, SC, TX, WA, WI. OUS.: None
Recall date
September 9, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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