PlainRecalls
FDA Devices Low Class III Terminated

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.

Reported: March 4, 2020 Initiated: January 16, 2020 #Z-1390-2020

Product Description

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.

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.

Details

Units Affected
4 units
Distribution
U.S. Distribution: CA, CO, IA, MN, NY, SC, VA
Location
Wayne, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Maquet Cardiovascular Us Sales, Llc. Units affected: 4 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 4, 2020. Severity: Low. Recall number: Z-1390-2020.