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U.S. Department of Health and Human Services

Class 2 Device Recall HLD Systems

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 Class 2 Device Recall HLD Systemssee related information
Date Initiated by FirmJanuary 24, 2013
Date PostedJuly 06, 2014
Recall Status1 Terminated 3 on February 10, 2015
Recall NumberZ-1995-2014
Recall Event ID 68580
Product Classification Device, pasteurization, hot water - Product Code LDS
ProductHLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
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.
Recalling Firm/
Manufacturer		 Cenorin, LLC
6324 S 199th Pl Ste 107
Kent WA 98032-2135
For Additional Information ContactJenette Bennett
253-395-2400 Ext. 236
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionCenorin 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.
Quantity in Commerce25 HLD systems
DistributionWorldwide Distribution - US (nationwide): CA, DE, FL, MA, MI, NY, PA, TX, UT, WA, and WI and the countries of Uruguay and Taiwan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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