Getinge 86-Series Medical Washer-Disinfector Recalled for Potential Hose Collapse
Maquet Cardiovascular is recalling 40 Getinge 86-Series Medical Washer-Disinfector units because the inlet pump hose may collapse, potentially preventing proper cleaning of medical instruments.
What this means for you
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 (medical device) where the failure could lead to improperly cleaned instruments, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling 40 units of the Getinge 86-Series Medical Washer-Disinfector (Part Number S-86682003). The recall is due to a possibility that the inlet pump hose may collapse during use. This collapse can result in low water pressure within the circulation system.
In the worst-case scenario, the collapse of the hose may result in the contents of the Washer Disinfector not being cleaned properly after the finished process. The device is designed for use in healthcare facilities and laboratories for the decontamination of reusable items such as instruments, utensils, anesthesia sets, and glassware.
The affected units were distributed worldwide, including in the United States (GA, IL, IN, MI, NC, OR, PA, VA) and foreign countries such as Australia, Canada, China, France, Germany, India, Japan, Korea, Netherlands, Saudi Arabia, South Africa, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and Ukraine. Specific serial numbers are listed in the agency's recall record. Healthcare facilities should stop using the affected units and contact the manufacturer for instructions on repair or replacement.
The recalled product
- Product
- Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glas
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Affected units
- 40
Distribution
Part of a larger recall action
This product is one of 2 recalled by Maquet Cardiovascular Us Sales, Llc 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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