Recall Z-1124-2021 ยท MEC Disinfector, Medical Devices
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, 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 surgic
| Date | Dec 21, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | On 01/12/2021 Getinge initiated a voluntary Medical Device in the U.S for the CM320 Series Washer Disinfector instructing consignees to inspect their device and that a correction kit is currently available and the correction will be completed at no cost to affected customers. |
| Quantity | 189 units total (Domestic 19 units, Foreign 170 units) |
| 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, Kuwa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.