Getinge Group Logistics America, LLC: Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer disinfector intended for washing, disinfecting and drying of surgical instruments,

Is my product affected?

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

• UPC 07340153700178
• UPC 07340153700185
• UPC 07340153700192
• UPC 07340153700208
• UPC 07340153700215
• UPC 07340153710153

Check against the official notice below — it lists the full affected range.

What happened

Getinge Group Logistics America, LLC is recalling the Getinge CM320 Series Washer Disinfector, a multi-chamber device used to wash, disinfect, and dry surgical instruments. The plastic inlet hose connections on these units may deform or break due to material fatigue or over-tightening of clamps. If a hose connection breaks, it can cause water leakage or spray, potentially resulting in burns to users or requiring the equipment to be taken out of service, causing procedural delays.

A total of 189 units have been distributed worldwide, including 19 units in the United States and 170 units in international locations. Affected units include multiple product codes and serial numbers specified in the recall record. The record does not specify a remedy or recommended action for consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide distribution including in the states of ND, PA, NC, VA, NE, MD, NY, MN and the countries of Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hong Kong, Norway, Slovakia, Slovenia, South Korea, Sweden, Japan, China, Netherland, Italy, Kuwait and Czech Republic. Quantity: 189 units total (Domestic 19 units, Foreign 170 units) 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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