Recall Z-2288-2018— Cenorin, LLC
Class II · Terminated
Class II FDA medical device recall by Cenorin, LLC, initiated 2018-04-09, terminated 2019-09-13. FDA's recall record names no specific 510(k) clearance for this event. 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: There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn..
- Recalling firm
- Cenorin, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-09
- Terminated
- 2019-09-13
- Firm location
- Kent, WA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.