FDA recall Z-1475-2020

Product

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

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

Key facts

Status

Terminated

Initiation date

2020-02-10

Report date

2020-03-18

Termination date

2023-09-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1475-2020