Recall Z-0587-06 ยท MSH Respirator, Surgical
Inovel LLC
Particulate Respirator and Surgical Mask, Inovel 3000 series Healthcare N95 Model Number(s): 3002N95-M, Lot Number 051130-161.
| Date | Mar 3, 2006 (initiated Feb 20, 2006) |
| Status | Terminated |
| Reason | Mislabeling-A customer reported mislabeled product display boxes. Review of complaint samples and inventory confirmed that some product display boxes are labeled with incorrect model/size number |
| Root cause | Other |
| Action | The recalling process will be initiated by 2/22/06. Distributors will be notified of the recall through a certified recall letter and they will in turn notify and recall product from their customers and return all affected product to Inovel. |
| Quantity | 40 cases ( 6, 400 respirators ) |
| Distribution | Nationwide (CA, FL, ME, NY, OH, WI) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051182 | INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS Inovel, LLC, May 19, 2005 |