Maquet Cardiovascular Us Sales, Llc: Medical Device Recall in 2020 - (Recall #: Z-1391-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: January 16, 2020

Date Posted: March 4, 2020

Recall Number: Z-1391-2020

Event ID: 84885

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.

Status: Terminated

Product Quantity: 7 units

Code Information:

Serial Numbers: WAA090094, WAA090112, WAA090409, WAA090521, WAA090757, WAA090805, WAA091170, WAA091288, WAA091292, WAA091454, WAA091460 WAA091463, WAA091477. UDI Code 07340153700048

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated