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Airo™ CPAP Mask Liners
Athfar 828 Inc · Model SMPL-AS-100 · UDI-DI 10850054813098
10
510(k) clearances
197
Adverse events (1 deaths)
6
Recalls
391
Facilities
Description
Sample - Airo™ CPAP Mask Liners - Box of 100 - Small
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-05-25 | Medline Industries Inc | Potential for mold contamination (Aspergillus vadensis) |
| 2017-12-11 | Medical Action Industries Inc | Product sterility potentially compromised. |
| 2016-03-31 | American Surgical Company | Product packaging defective compromising sterility |
| 2016-03-31 | American Surgical Company | Product packaging defective compromising sterility |
| 2009-07-21 | Coloplast Corp Skin Care Div | Coloplast determined that a portion of one lot of InterDry" Ag Lot number 1789435, did not meet the product specification for silver content. In this portion of the lot antimicrob |
| 2006-02-09 | 3M Company / Medical Division | After reviewing manufacturing records it has been determined that these lots inadvertently were not sterilized after packaging in individual boxes labeled as sterile product. |
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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.