FDAClass IIJune 15, 2022

Getinge CM320 WUWD Series Washer Disinfector-For use as recall

Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical…

Why was Getinge CM320 WUWD Series Washer Disinfector-For use as 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: 07340153700192 Serial Numbers: W50026718 W50029991 WAA081312 W50039234 WAA062340 WAA062341 WAA070619 WAA085063 WAA089556 WAA093936 WAA094247

Product
Getinge CM320 WUWD 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
11 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)
Open FDA enforcement record Latest recalls