Recall Z-1390-2020 ยท MEC Disinfector, Medical Devices
Maquet Cardiovascular Us Sales, Llc
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods.
| Date | Jan 16, 2020 |
| Status | Terminated |
| Reason | Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have been no adverse events reported resulting in serious illness or injuries. |
| Root cause | Employee error |
| Action | Getinge issued an Urgent Medical Device Recall Correction letter to U.S. consignees via FedEx Priority Overnight delivery with signature proof of delivery on January 16, 2020. Letter provides identification of the issue, health risk and action to take. Customers were advised to examine your inventory immediately, complete and sign the MEDICAL DEVICE RECALL - RESPONSE FORM to acknowledge that you have received this notification, return the completed form to Getinge Disinfection AB by e-mailing a scanned copy to swic46-series.us@getinge.com or by faxing the form to 1-800-574-5051. Should you ha |
| Quantity | 4 units |
| Distribution | U.S. Distribution: CA, CO, IA, MN, NY, SC, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.