FDADecember 21, 2020device

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. ...

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

getinge group logistics americagetingegetinge group

UPCs

073401537001780734015370018507340153700192073401537002080734015370021507340153710153

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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