Recall Z-1248-2022 ยท MEC Disinfector, Medical Devices
Getinge Usa Sales Inc
Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WU
| Date | Apr 13, 2022 |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Process control |
| Action | 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 t |
| Quantity | 4 units |
| Distribution | US Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.