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Legend Aerospace
Legend Aerospace, Inc. · Model LAI-5532A1-105 · UDI-DI 00850057805055
0
510(k) clearances
28
Adverse events (1 deaths)
5
Recalls
12
Facilities
Description
Emergency Medical Kit 105 LAI-5532A1-105
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-15 | SunMed Holdings, LLC | Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. |
| 2025-12-15 | SunMed Holdings, LLC | Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. |
| 2025-12-15 | SunMed Holdings, LLC | Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. |
| 2025-12-15 | SunMed Holdings, LLC | Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. |
| 2025-05-15 | SunMed Holdings, LLC | The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in t |
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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.