Medical device recalls Moderate risk

HLD Systems 600 Series Washer/Pasteurizer recalled over fire hazard

Recall date
April 9, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Cenorin, LLC recalls HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610…
Recall number
Z-2288-2018
FDA classification
Class II
Brand / firm
Cenorin, LLC
Sold / distributed
Worldwide Distribution - US Nationwide in the states of CA, FL, IN, NC, NE, UT & WV; and countries of Malaysia and Taiwan

Why it was recalled

There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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