Kent, WA, United States
Cenorin, LLC recalls
1 recall recorded since 2018, most recently on 9 April 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 9 April 2018
- Terminated
- 13 September 2019
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2288-2018
- 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 pasteu
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.