FDA-Device2018-07-04Class II
HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Clean and thermally disinfect medical devices using full immersion pasteurization
Cenorin, LLC
Hazard
There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn.
Sold states
Worldwide Distribution - US Nationwide in the states of CA, FL, IN, NC, NE, UT & WV; and countries of Malaysia and Taiwan
Affected count
14 units
Manufactured in
6324 S 199th Pl, Suite 107, Kent, WA, United States
Products
HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Clean and thermally disinfect medical devices using full immersion pasteurization
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2288-2018Don't want to check this manually?
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