Recall Z-2288-2018 ยท LDS Device, Pasteurization, Hot Water
Cenorin, LLC
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
| Date | Apr 9, 2018 |
| Status | Terminated |
| Reason | There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn. |
| Root cause | Nonconforming Material/Component |
| Action | 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 im |
| Quantity | 14 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of CA, FL, IN, NC, NE, UT & WV; and countries of Malaysia and Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.