Getinge Group Logistics America, LLC recalls Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer disinfector intended for washing, disin…

Recall date

December 21, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1124-2021

FDA classification

Class II

Brand / firm

Getinge Group Logistics America, LLC

Sold / distributed

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, Kuw…

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.