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Terminated

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

FDA Recall Z-1995-2014 · Posted 2014-07-06

Recalling FirmCenorin, LLC
Recall StatusTerminated
Product CodeLDS
Date Initiated2013-01-24
Date Terminated2015-02-10
Product Quantity25 HLD systems

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.

Firm Action

Cenorin sent a Notification letter dated December 18, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated: Cenorin has developed an upgrade to mitigate this issue as well as provide additional process control and system monitoring benefits. Cenorin included a Return Response form with the recall letter to be completed and return. For questions contact HLD Systems Sales Representative for questions.

Root Cause

Device Design

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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