FDAClass IIJune 15, 2022

Getinge CM320-2 CHAMBER WU Series Washer Disinfector recall

Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical…

Why was Getinge CM320-2 CHAMBER WU Series Washer Disinfector recalled?

Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection

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?

UDI-DI: 07340153700185 Serial Numbers: W50034570 WAA070170 WAA070618 WAA081312

Product
Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical…
Recalling firm
Getinge Usa Sales Inc
Quantity
4 units
Distribution
US Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA.
Recall date
June 15, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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