medical Class II Updated 2021-02-24

Getinge Group Logistics America, LLC recalls Getinge CM320 Series Washer Disinfector - Product Usage: A m

Recalled Product

Getinge CM320 Series Washer Disinfector - Product Usage: A 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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Code/Part Number: CM320 4 WUWD, CM320 3 WWD, CM320K661, CM320K671, CM320K689, CM320K706, CM320K730, CM320WU, CM320WU K981, CM320WUWD. Serial Number: 31253, 31260, 31299, 31286, W50026718, W50027250, W50029991, W50034570, W50039234, WAA070170, WAA081312, WAA062340, WAA062341, WAA070619, WAA085063, WAA089556, WAA093936, WAA094247, WAA070618. UDI Code: 07340153700178 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
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