HLD 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

There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn.

On 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 [email protected] 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 [email protected] within 5 business days. Response is required. Customers with questions, please email Cenorin at [email protected] 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.