Recall Z-1124-2021— Getinge Group Logistics America, LLC

Class II FDA medical device recall by Getinge Group Logistics America, LLC, initiated 2020-12-21, terminated 2022-07-20. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..

Recalling firm

Getinge Group Logistics America, LLC

Classification

Class II

Status

Terminated

Initiated

2020-12-21

Terminated

2022-07-20

Firm location

Wayne, NJ, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.