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U.S. Department of Health and Human Services

Class 2 Device Recall HLD Systems 600 Series Washer/Pasteurizer

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 Class 2 Device Recall HLD Systems 600 Series Washer/Pasteurizersee related information
Date Initiated by FirmApril 09, 2018
Create DateJune 26, 2018
Recall Status1 Terminated 3 on September 13, 2019
Recall NumberZ-2288-2018
Recall Event ID 80295
Product Classification Device, pasteurization, hot water - Product Code LDS
ProductHLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Clean and thermally disinfect medical devices using full immersion pasteurization
Code Information Serial Numbers: 611503, 611504, 611505, 611506, 611601, 611602, 611603, 611604, 611605, 611606, 611607, 611608, 611609 & 611610
FEI Number 3004153171
Recalling Firm/
Manufacturer		 Cenorin, LLC
6324 S 199th Pl
Suite 107
Kent WA 98032
For Additional Information Contact
800-426-1042
Manufacturer Reason
for Recall		There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn April 9, 2018, Cenorin telephoned customers and then followed-up with a formal letter titled URGENT MEDICAL DEVICE RECALL via email. To mitigate this quality issue, Cenorin has a Corrective Kit available to replace the existing terminal blocks in the Washer/Pasteurizer as the long-term solution. In the meantime, here is how you can help with the recall process: 1. Please immediately examine your inventory for the recalled Washer/Pasteurizers listed and quarantine them to prevent further distribution. In addition, if you have further distributed this product, please notify your customers immediately using the enclosed notice. 2. If the Washer/Pasteurizers does not exhibit any of the symptoms of failure as noted, continue to use the Washer/Pasteurizers as normal until the service can be completed. If the Washer/Pasteurizers exhibit any of the symptoms of failure, immediately cease its use and contact Cenorin immediately at recall@cenorin.com or call Technical Support at 800-426-1042 ext. 224. 3. Complete the Recall Acknowledgement & Response Form and return to Cenorin as noted on form via email to recall@cenorin.com within 5 business days. Response is required. Customers with questions, please email Cenorin at recall@cenorin.com or call 253-395-2400 or toll-free 800-426-1042, extension 236 during the hours of business Monday through Friday, 7:30AM to 4:30PM, Pacific Standard Time.
Quantity in Commerce14 units
DistributionWorldwide Distribution - US Nationwide in the states of CA, FL, IN, NC, NE, UT & WV; and countries of Malaysia 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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