Recall Z-0951-2017 ยท LGZ Warmer, Thermal, Infusion Fluid
Natus Manufacturing Limited
Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by
| Date | Oct 15, 2016 |
| Status | Terminated |
| Reason | The fuse blows during initial power up or after a period of time. This results in a complete loss of power to the Cabinet and in some cases has resulted in the fuse cover for the power inlet melting slightly. |
| Root cause | Mixed-up of materials/components |
| Action | Natus Manufacturing Limited sent an "Urgent Field Safety Notice" letter dated April, 2016, via email. The letter described the problem and the product involved in the recall. Informed the consignees that a repair kit to correct the issue is available for repair of affected units. Requested consignees to complete the attached form and Faxto 847-949-6031 or e-mail it to Natus Quality Programs. In turn the firm will send the repair kit. For questions contact Technical Service at 888-496-2887. For questions regarding this recall call 888-496-2887. |
| Quantity | 31 |
| Distribution | Worldwide Distribution - US including NJ, NC, TX, IL, VA, NY, FL, CA, MS, WA, IN, and MA. and Internationally to Canada and Costa Rica. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132110 | NATUS WARMETTE BLANKET AND DUAL CABINETS Natus Nicolet Ireland, Ltd., Oct 3, 2013 |