Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, dis
Summary
The FDA issued a Class II for Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber by Getinge Usa Sales Inc. Reason: Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shoc.
Details
Source
Device Recall
External ID
Z-1248-2022
Action Date
2022-06-15
Status
Ongoing
Category
device
Product Description
Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WU
Lot/Code Info: UDI-DI: 07340153700185 Serial Numbers: W50034570 WAA070170 WAA070618 WAA081312
Quantity Affected: 4 units
Reason for Recall
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
Distribution
US Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-13
Company
Wayne, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 178 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Getinge Usa Sales Inc has 48 FDA actions in our database, including 48 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Getinge Usa Sales Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Getinge Usa Sales Inc have FDA actions?
Getinge Usa Sales Inc has 48 FDA actions in our database, including 48 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1248-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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