Recall Z-1995-2014 ยท LDS Device, Pasteurization, Hot Water
Cenorin, LLC
HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
| Date | Jul 6, 2014 (initiated Jan 24, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Cenorin 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 | 25 HLD systems |
| Distribution | Worldwide Distribution - US (nationwide): CA, DE, FL, MA, MI, NY, PA, TX, UT, WA, and WI and the countries of Uruguay and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.