FDA-Device2016-10-26Class II
CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures
Hazard
The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
Sold states
Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.
Affected count
N/A
Manufactured in
525 French Rd, N/A, Utica, NY, United States
Products
CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0135-2017More ConMed Corporation recalls
- FDA-Device2026-06-24ConMed AirSeal 5mm Access Port recalled for potential overpressure alerts during laparoscopy
- FDA-Device2026-06-24ConMed AirSeal 12mm Access Port recalled for overpressure alert malfunction
- FDA-Device2026-06-24ConMed AirSeal 12mm Access Port recalled for overpressure alert risk
- FDA-Device2026-06-24ConMed AirSeal 5mm Access Port recalled for potential overpressure alerts
- FDA-Device2026-06-24ConMed AirSeal 8mm Access Port recalled for potential overpressure alerts
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