The Recall Desk

FDA (Devices) recall action 79641

Getinge Disinfection Ab recalled 2 products on 2018-04-25

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
2018-04-25
Critical
0
Units
340

Why these products were recalled

There is potential for a cart with disinfected goods to unload without the trolley being docked. Disinfected goods could end up falling to the floor causing risk to nearby users and damage to goods and equipment.

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.

1–2 of 2

  • HighFDA (Devices)··2018-04-25

    Getinge Washer-Disinfector Accessory Recall for Potential Cart Unloading Hazard

    Getinge is recalling 170 automated loading/unloading accessories for Washer-Disinfector 86 Series units due to a risk of disinfected goods falling to the floor.

    Product
    Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector 07340153700246, 07340153700253, 07340153700260, 07340153700277 Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transpor
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-04-25

    Getinge Washer-Disinfector Accessory Recall Due to Unloading Hazard

    Getinge is recalling 170 automated loading/unloading systems for Washer-Disinfector 88 Series units. The recall addresses a risk that disinfected goods may fall to the floor if the trolley is not docked.

    Product
    Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 88 Series UDI Info: 07340153700109, 07340153700116 Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transport system for unloading carriers (wash carts) from Getinge 86/
    Category
    Distribution
    0 states