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

FDA device recall Z-1995-2014 · posted 2014-07-06 · Terminated

Recall details

Recalling firm

Cenorin, LLC

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.

Action taken

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

Status

Terminated

Product code

LDS

Quantity affected

25 HLD systems

Distribution

Worldwide Distribution - US (nationwide): CA, DE, FL, MA, MI, NY, PA, TX, UT, WA, and WI and the countries of Uruguay and Taiwan.

Date initiated

2013-01-24

Date posted

2014-07-06

Date terminated

2015-02-10

Location

Kent, WA