FDA recall Z-1390-2020

Maquet Cardiovascular Us Sales, Llc · Class III · device

Product

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.

Distribution

U.S. Distribution: CA, CO, IA, MN, NY, SC, VA

Key facts

Status
Terminated
Initiation date
2020-01-16
Report date
2020-03-04
Termination date
2023-10-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1390-2020