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A&Z Pharmaceutical
A & Z Pharmaceutical Inc. · Model M8004 · UDI-DI 00850024750081
10
510(k) clearances
195
Adverse events
3
Recalls
225
Facilities
Description
The N95 Respirator is designed to help provide respiratory protection for the user. This product has a filter efficiency of 95% or greater against solid and liquid aerosols free of oil. This product contains no components made from natural rubber latex.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-09 | O&M HALYARD, INC. | One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user. |
| 2008-07-23 | Inovel LLC | Display boxes labeled as FRN95-MLEZ, Medium/Large Size Respirators were inadvertently mixed with Display Boxes labeled for FRN95-SEZ Small Size Respirators. |
| 2006-02-20 | Inovel LLC | Mislabeling-A customer reported mislabeled product display boxes. Review of complaint samples and inventory confirmed that some product display boxes are labeled with incorrect mod |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.