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Mydcombi
Eyenovia, Inc. · Model FG-16427 · UDI-DI 00860009909700
KYX
Prescription
10
510(k) clearances
263
Adverse events (3 deaths)
17
Recalls
276
Facilities
Description
A reusable non-sterile component of the MydCombi drug delivery system. Working in conjunction with the Cartridge, this base contains the drive system that allows actuation of the mist. It also contains the power source and interfaces with an external charging source.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-04 | Avanos Medical, Inc. | The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers. |
| 2024-03-04 | Avanos Medical, Inc. | The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers. |
| 2024-03-04 | Avanos Medical, Inc. | The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers. |
| 2023-03-20 | Baxter Healthcare Corporation | ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter. |
| 2022-07-22 | Baxter Healthcare Corporation | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. |
| 2022-07-22 | Baxter Healthcare Corporation | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. |
| 2022-07-22 | Baxter Healthcare Corporation | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. |
| 2022-07-22 | Baxter Healthcare Corporation | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. |
| 2022-07-22 | Baxter Healthcare Corporation | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. |
| 2022-07-22 | Baxter Healthcare Corporation | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. |
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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.