Reported Feb 24, 2021 · Terminated
Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer disinfector intended for washing,…
Getinge Group Logistics America, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Getinge Group Logistics America, LLC · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- Getinge CM320 Series
- Washer Disinfector - Product UsageA multi chamber washer disinfector intended for washing, disinfecting and drying of surgical instruments, containers, operating theatre shoes and operating theatre accessories normally used in hospitals and central disinfection facilities. The disinfected items must be further processed through terminal sterilization before use in any surgical procedure
- Lot codes and dates
- Product Code/Part Number
CM320 4 WUWDCM320 3 WWDCM320K661CM320K671CM320K689CM320K706CM320K730CM320WUCM320WU K981CM320WUWD
- Serial Number
31253312603129931286W50026718W50027250W50029991W50034570W50039234WAA070170WAA081312WAA062340WAA062341WAA070619WAA085063WAA089556WAA093936WAA094247WAA070618
- UDI Code07340153700178 GETINGE CM320WO CM320 2 CHAMBER WO 07340153700185 GETINGE CM320WU CM320 2 CHAMBER WU 07340153700192 GET/NGE CM320WUWO CM320 4 CHAMBER WUWO 07340153700208 GETINGE CM320WWO CM320 3 CHAMBER WWO 07340153700215 GETINGE CM320WWWO CM320 4 CHAMBER WWWO 07340153710153 GETINGE CM320WOK966 CM320 2 CHAMBER WO
- Product Code/Part Number
- Amount recalled
- 189 units total (Domestic 19 units, Foreign 170 units)
Where it was sold
Why it was recalled
The potential that the plastic inlet hose connections may deform or break as a result of material fatigue and/or over tightening of the clamps. A broken hose connection may lead to a hazardous situation of water leakage or water spray. The water leakage or water spray may result in a burn to the user and/or an inconvenience due to a procedural delay if the Washer Disinfector is taken out of service.
This product could cause temporary or reversible health problems — stop using it.
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