Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ, Expiration Date: 07/13/2010.
FDA device recall Z-1576-2009 · posted 2009-07-13 · Terminated
Recall details
- Recalling firm
- Inovel LLC
- Reason for recall
- Display boxes labeled as FRN95-MLEZ, Medium/Large Size Respirators were inadvertently mixed with Display Boxes labeled for FRN95-SEZ Small Size Respirators.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- MSH
- Quantity affected
- 80 cases
- Distribution
- US (Illinois only).
- Date initiated
- 2008-07-23
- Date posted
- 2009-07-13
- Date terminated
- 2009-07-17
- Location
- Culver City, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP (K042267) | Inovel, LLC | 2004-09-30 |