PlainRecalls
FDA Devices Moderate Class II Terminated

Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203

Reported: March 18, 2020 Initiated: February 10, 2020 #Z-1475-2020

Product Description

Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203

Reason for Recall

Potential leakage that may occur due to ruptured spot welds in the chamber, could generate a situation for the user such as risk for slipping or infection from contaminated water

Details

Units Affected
146 US
Distribution
Nationwide Foreign: Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Iraq, Iran, Ireland, Israel, Italy, Japan, Kenya, Lithuania, Netherlands, New Zealand, Norway, Poland, Qatar, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom
Location
Wayne, NJ

Frequently Asked Questions

What product was recalled?
Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203. Recalled by Maquet Cardiovascular Us Sales, Llc. Units affected: 146 US.
Why was this product recalled?
Potential leakage that may occur due to ruptured spot welds in the chamber, could generate a situation for the user such as risk for slipping or infection from contaminated water
Which agency issued this recall?
This recall was issued by the FDA Devices on March 18, 2020. Severity: Moderate. Recall number: Z-1475-2020.