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Recall Observatory FDA recall evidence

Device product

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

Z-2288-2018

April 09, 2018

Class II

Product summary

Firm
Cenorin, LLC
Event
Event 80295
Status
Terminated
Classification
Class II
Quantity
14 units
Official record key
device-enforcement:Z-2288-2018

Official wording

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

Code information: Serial Numbers: 611503, 611504, 611505, 611506, 611601, 611602, 611603, 611604, 611605, 611606, 611607, 611608, 611609 & 611610

Distribution pattern: Worldwide Distribution - US Nationwide in the states of CA, FL, IN, NC, NE, UT & WV; and countries of Malaysia and Taiwan

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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