FDAApril 9, 2018device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn.
What to do
FDA enforcement status: Terminated
Brands named
cenorin
UPCs
0085249007009
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical devices2017-06-07
- FDAThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136 Forced air dryer for medical devices2017-06-07
- FDAThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340 Forced air dryer for medical devices2017-06-07
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