Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, Model: CM320 WUWD
- Company
- Getinge Usa Sales Inc
- Recall Initiated
- April 13, 2022
- Recall Number
- Z-1249-2022
- Quantity
- 11 units
- Firm Location
- Wayne, NJ
Reason for Recall
Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection
Distribution
US Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA.
Lot / Code Info
UDI-DI: 07340153700192 Serial Numbers: W50026718 W50029991 WAA081312 W50039234 WAA062340 WAA062341 WAA070619 WAA085063 WAA089556 WAA093936 WAA094247
Root Cause
Process control
Action Taken
Getinge issued to U.S. consignees Medical Device Correction Letter dated April 13, 2022 via FedEx delivery. Letter states reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have any Getinge CM320-series Washer Disinfectors with the REF number/serial numbers listed on page 1. You can continue to use Getinge CM320-series Washer Disinfectors until the corrective action is performed; there are no precautionary actions necessary. 2. Please complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM (page 5) to acknowledge that you have received this notification. A Getinge service technician will review the Installation Checklist and verify that each of the steps were performed to ensure continual safe operation of your cart washer(s). This review and verification will be performed. Questions contact your Getinge representative or Technical Support please call (888) 943-8872 (options 4,2,1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). Technical Support can also be reached via email at techsupportIC.us@getinge.com.