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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.
FEI Number 3004153171
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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