FDAClass IIJuly 26, 2023

GEM Flow Coupler Monitor recall

GEM FLOW COUPLER Monitor, PN 5156-00000-011

Why was GEM Flow Coupler Monitor recalled?

An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active channel prior to powering down.

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 00844735006148, all serial numbers

Product
GEM FLOW COUPLER Monitor, PN 5156-00000-011
Recalling firm
Baxter Healthcare Corporation
Quantity
122 units
Distribution
US
Recall date
July 26, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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