Recall Z-0843-2008 ยท DQA Oximeter
Nonin Medical, Inc
Nonin Model 2500 PalmSAT handheld pluse Oximeter , Nonin Medical, Inc., Plymouth, MN USA
| Date | Apr 11, 2008 (initiated Oct 11, 2007) |
| Status | Terminated |
| Reason | Incorrect Label: The label on the back of the device may show Model 2500A rather than Model 2500. |
| Root cause | Error in labeling |
| Action | An Urgen Field Action letters was sent (10/11/07) to Nonin distributors who received the potentially mislabeled product. The letters provided labeling differences and included instructions for notifying their customers, with a response form to be returned to Nonin. For additional information please contact Kim Aves at 763-577-3196. |
| Quantity | 240 |
| Distribution | Worldwide Distribution ---- USA including states of ME, SC, SD, CA, MO, NY, MI, FL, IL, PA, NC, CT, and TX, and countries of Canada, Greece, Russia, Italy, Sweden, Australia, & Japan. |
| FDA record | Open on fda.gov |