Recall Z-0901-2015 ยท DQA Oximeter
Nonin Medical, Inc
SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (REF 9824-001, 3-Wavelength), 8004CA (REF 9705-001, 4-Wavelength), with associated materials (INT-100 cable, operator's manual; and Quick Start Guide). Sensors are single-packed in a pouch, then multi-packed, 20 per shelf-box.
| Date | Dec 31, 2014 (initiated Nov 25, 2014) |
| Status | Terminated |
| Reason | Nonin Medical is conducting a recall of certain regional oximetry sensors and associated products. They have received reports of signal loss during use of our shortcabled regional oximetry sensors with diaphoretic patients. No injury or illness have been reported. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were sent a Nonin letter dated November 24, 2014. The letter described the problem and the product affected. They requested consignees to discontinue the use of the products and return it to Nonin. Consignees were asked to complete and return the "Medical Device Market Withdrawal Return Response Form". For questions and additional information they can contact James H. Russell at 763-577-2260 or e-mail jim.russell@nonin.com. |
| Quantity | 5892 (5452 US, 440 OUS) |
| Distribution | To be provided later. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132402 | SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM Nonin Medical, Inc., Feb 21, 2014 |