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Recall Observatory FDA recall evidence

Device product

HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.

Z-1995-2014

January 24, 2013

Class II

Product summary

Firm
Cenorin, LLC
Event
Event 68580
Status
Terminated
Classification
Class II
Quantity
25 HLD systems
Official record key
device-enforcement:Z-1995-2014

Official wording

Reason: 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.

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.