Z-1777-2019 Class II Terminated

Recalled by Maquet Cardiovascular Us Sales, Llc — Wayne, NJ

Recall Details

Product Type
Devices
Report Date
June 19, 2019
Initiation Date
May 20, 2019
Termination Date
December 15, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4 units

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution - US Nationwide GA, IL, IN, MI, NC, OR, PA, VA Foreign: Australia, Canada, China, France, Germany, India, Japan, Korea, Netherlands, Saudi Arabia, South Africa, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, Ukraine

Code Information

Serail Numbers: WAA088731, WAA089124 , WAA089128, WAA089586