Recall Z-1391-2020— Maquet Cardiovascular Us Sales, Llc
Class III · Terminated
Class III FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2020-01-16, terminated 2023-10-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 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.. 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..
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2020-01-16
- Terminated
- 2023-10-23
- Firm location
- Wayne, NJ, United States
Product description
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.