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ChitoZolve
Gyrus ACMI, LLC · Model CNS155 · UDI-DI 00821925044166
LYA
Prescription
1
510(k) clearances
203
Adverse events (3 deaths)
2
Recalls
105
Facilities
Description
Dissolvable Chitosan Intranasal Splint ChitoZolve 1.5 cm x 5.0 cm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-07-27 | GELITA MEDICAL GMBH | In routine bioburden testing, higher than acceptable levels of Endotoxins were observed. |
| 2006-07-11 | Porex Surgical, Inc. | Device contains a trace amount of amine via introduction through an intermediate supplied by a third party raw material |
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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.