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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Getinge Disinfection Ab is recalling 170 units of the Getinge AGS, FSLC, FSUC, and RC accessories intended for the Washer-Disinfector 86 Series. These automated loading and unloading systems function as conveyor or transport mechanisms for wash carts and are considered accessories to the medical washer-disinfectors. The affected products were distributed worldwide, including in the United States and numerous international markets.
The recall is being issued because there is a potential for a cart containing disinfected goods to unload without the trolley being properly docked. If this occurs, the disinfected goods could fall to the floor, creating a risk of injury to nearby users and causing damage to the goods and equipment.
Healthcare facilities and users should identify the affected units by checking the serial numbers listed in the recall documentation. Users should contact Getinge Disinfection Ab for instructions on how to resolve the issue and ensure the safety of their equipment.
The recalled product
- 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…
- Manufacturer
- Getinge Disinfection Ab
- Affected units
- 170
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI Info: 86 Series Washer Disinfector 07340153700246
- 07340153700253
- 07340153700260
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Getinge Disinfection Ab under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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