Recall Z-1576-2009 ยท MSH Respirator, Surgical
Inovel LLC
Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ, Expiration Date: 07/13/2010.
| Date | Jul 13, 2009 (initiated Jul 23, 2008) |
| Status | Terminated |
| Reason | Display boxes labeled as FRN95-MLEZ, Medium/Large Size Respirators were inadvertently mixed with Display Boxes labeled for FRN95-SEZ Small Size Respirators. |
| Root cause | Packaging process control |
| Action | The recalling process was initiated on July 23, 2007. The affected distributor was notified of the recall through a certified recall letter with an attached Customer Response card. The distributor was instructed to notify and obtain recall product from their customers and return all affected product to Inovel. Direct questions about the recall to Inovel at 1-866-546-6835. |
| Quantity | 80 cases |
| Distribution | US (Illinois only). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042267 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP Inovel, LLC, Sep 30, 2004 |