Z-1995-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 16, 2014
- Initiation Date
- January 24, 2013
- Termination Date
- February 10, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 HLD systems
Product Description
HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
Reason for Recall
The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperature reading. This caused the water to remain at ambient temperature throughout the pasteurization cycle rather than using hot water.
Distribution Pattern
Worldwide Distribution - US (nationwide): CA, DE, FL, MA, MI, NY, PA, TX, UT, WA, and WI and the countries of Uruguay and Taiwan.
Code Information
610601, 610603, 610703, 610704, 610705, 610707, 610708, 610802, 610803, 610804, 610901, 610903, 610904, 610905, 611001, 611002, 611004, 611101, 611102, 611103, 611201, 611202, 611203, 610902L, 611204.