Cenorin, LLC

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
1
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2288-2018Class IIHLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HApril 9, 2018
Z-3033-2017Class IIThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340June 7, 2017
Z-3034-2017Class IIThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1June 7, 2017
Z-3032-2017Class IIThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136June 7, 2017
Z-1729-2014Class IIHLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filleApril 24, 2014
Z-1995-2014Class IIHLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.January 24, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K183444Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High LeSeptember 9, 2019