Getinge 86-Series Medical Washer-Disinfector Recalled for Potential Hose Collapse
Maquet Cardiovascular is recalling four 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 injuries or illnesses have been reported in the source text.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling four units of the Getinge 86-Series Medical Washer-Disinfector (Part Numbers S-8666 and S-8668). The recall is due to a possibility that the inlet pump hose might collapse during use.
If the hose collapses, it may result in low water pressure within the circulation system. In the worst-case scenario, this could result in the contents of the Washer-Disinfector not being cleaned properly after the finished process. The affected units are identified by serial numbers WAA088731, WAA089124, WAA089128, and WAA089586.
The recalled devices were distributed worldwide, including in the United States (GA, IL, IN, MI, NC, OR, PA, VA) and in 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. Healthcare facilities and laboratories using these devices for decontamination of reusable items such as instruments, utensils, anesthesia sets, and glassware should contact the recalling firm for instructions.
The recalled product
- Product
- Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: 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, a
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Affected units
- 4
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 (4)
- Serail Numbers: WAA088731
- WAA089124
- WAA089128
- WAA089586
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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