The Recall Desk

FDA (Devices) recall action 84885

Maquet Cardiovascular Us Sales, Llc recalled 2 products on 2020-03-04

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-03-04
Critical
0
Units
11

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • LowFDA (Devices)··2020-03-04

    Getinge 46-Series Washer Disinfector Recalled Due to Missing Water Intake Components

    Maquet Cardiovascular is recalling four Getinge 46-Series Washer Disinfector units because they lack necessary water intake components, preventing proper installation.

    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
    Category
    Distribution
    7 states
  • LowFDA (Devices)··2020-03-04

    Getinge 46-Series Washer Disinfector Recalled Due to Missing Water Intake

    Maquet Cardiovascular is recalling 7 Getinge 46-Series Washer Disinfector units because they lack the necessary water intake components for proper installation.

    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
    Category
    Distribution
    7 states