FDA recall Z-2288-2018

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

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

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

Key facts

Status

Terminated

Initiation date

2018-04-09

Report date

2018-07-04

Termination date

2019-09-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kent, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2288-2018