Z-2288-2018 Class II Terminated

Recalled by Cenorin, LLC — Kent, WA

Recall Details

Product Type
Devices
Report Date
July 4, 2018
Initiation Date
April 9, 2018
Termination Date
September 13, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14 units

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

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