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Makrite Industries Inc.
Makrite Hubei Industrial Co., Ltd. · Model 9603 · UDI-DI 06973875280751
10
510(k) clearances
194
Adverse events
3
Recalls
226
Facilities
Description
NIOSH approved and FDA cleared cone style N95 disposable respirator, medium/large size.
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.