Nonin Model 2500 PalmSAT handheld pluse Oximeter , Nonin Medical, Inc., Plymouth, MN USA
FDA device recall Z-0843-2008 · posted 2008-04-11 · Terminated
Recall details
- Recalling firm
- Nonin Medical, Inc
- Reason for recall
- Incorrect Label: The label on the back of the device may show Model 2500A rather than Model 2500.
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- DQA
- Quantity affected
- 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.
- Date initiated
- 2007-10-11
- Date posted
- 2008-04-11
- Date terminated
- 2011-12-18
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODEL 2500A PALMSAT PULSE OXIMETER (K050056) | Nonin Medical, Inc. | 2005-06-21 |
| MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500 (K002690) | Nonin Medical, Inc. | 2000-10-11 |