Recall Z-0036-2011 ยท LDS Device, Pasteurization, Hot Water
Cenorin
HLD SYSTEM 520 is a two-tank Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). Each unit has a metal serial tag that is riveted to the enclosure of the unit and it is labeled in part: "HLD SYSTEMS 520***FOR SALES.SERVICE.SUPPLIES CALL***Cenorin*** Kent, WA 98032***P:800.426.1042***F: 253.395.2650***www.cenorin.com". Medical Device Cleaning and High Level Disinfect
| Date | Oct 12, 2010 (initiated Jun 7, 2010) |
| Status | Terminated |
| Reason | The water level sensor in the Medical Device Cleaning and High Level Disinfection (Washer/Pasteurizer) is sensitive to externally induced vibration noise, and it produces a false signal that the water level in the tank is full while it is only 75% full. It could present a health risk of biological hazard because the medical devices are not being adequately cleaned or pasteurized with enough wat |
| Root cause | Component design/selection |
| Action | On June 7, 2010, firm, CENORIN, sent "URGENT: MEDICAL DEVICE RECALL" Initial Notification letter with Recall Response Form, Series 500 Water Level Check Instructions, and the Water Level Switch Upgrade Kit Instruction (service kit P/N # 082395-00) to their consignees. The firm also sent these documents in Spanish language to their foreign consignees. The letter describes the recall product as HLD Systems Medical Device Cleaning and High Level Disinfection Series 500 Washer/Pasteurizer-Model 540, Model 540HT and Model 520. Customers are advised to call the Customer Service at 1-800-426-140 |
| Quantity | 9 units |
| Distribution | Worldwide distribution:USA and countries including: Costa Rica, Ecuador, Japan, Mexico, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.