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Millennium
Avalign Technologies, Inc. · Model 72-136030 · UDI-DI 00190776416218
10
510(k) clearances
563
Adverse events (13 deaths)
5
Recalls
220
Facilities
Description
ENT Atomizer with Nasal Tip, Removable Tip, 1.4oz capacity, Glass Bottle, Brass Sprayer and Cap, Glass Tube with Brass Tip, EPDM 60 Duro Gasket, White Teflon Washer
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-19 | Karl Storz Endoscopy | Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance. |
| 2024-02-27 | Karl Storz Endoscopy | Inadequate reprocessing validation evidence |
| 2023-10-24 | Karl Storz Endoscopy | The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the pa |
| 2013-05-24 | Gyrus Acmi, Incorporated | lack of sterility assurance |
| 2006-01-20 | Acclarent Inc | Device sterility may be compromised as evidenced by a loss of package integrity. |
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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.