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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Maquet Cardiovascular Us Sales, Llc: Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse during use result in low water pressure within the circulation system and, in the worst case scenario, can result in the contents of the Washer Disinfector not being cleaned properly after finished process.

Agency Publication Date: June 13, 2019
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Affected Products

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, and glassware are handled for decontamination purposes.

Serail Numbers: WAA088731, WAA089124 , WAA089128, WAA089586

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 glassware are handled for decontamination purposes.

Serail Numbers: WAA088623 WAA088625 WAA088637 WAA088639 WAA088686 WAA088775 WAA088776 WAA088777 WAA088819 WAA088825 WAA088866 WAA088894 WAA088917 WAA088948 WAA088949 WAA088950 WAA088951 WAA089058 WAA089060 WAA089123 WAA089137 WAA089138 WAA089141 WAA089143 WAA089201 WAA089247 WAA089251 WAA089262 WAA089269 WAA089295 WAA089298 WAA089323 WAA089327 WAA089334 WAA089337 WAA089350 WAA089363 WAA089416 WAA089436 WAA089649

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82975
Status: Resolved
Manufacturer: Maquet Cardiovascular Us Sales, Llc
Manufactured In: United States
Units Affected: 2 products (4 units; 40 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.