Particulate Respirator and Surgical Mask, Inovel 3000 series Healthcare N95 Model Number(s): 3002N95-M, Lot Number 05113
FDA device recall Z-0587-06 · posted 2006-03-03 · Terminated
Recall details
- Recalling firm
- Inovel LLC
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MSH
- Quantity affected
- 40 cases ( 6, 400 respirators )
- Distribution
- Nationwide (CA, FL, ME, NY, OH, WI)
- Date initiated
- 2006-02-20
- Date posted
- 2006-03-03
- Date terminated
- 2007-01-29
- Location
- Culver City, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS (K051182) | Inovel, LLC | 2005-05-19 |