FDA-Device2022-02-23Class II
Destino Twist 14F (also branded as Guidestar 14F)
Oscor Inc.
Hazard
There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
Sold states
Distribution to TN and PA in USA OUS distribution to Czech Republic
Affected count
549 units
Manufactured in
3816 Desoto Blvd, N/A, Palm Harbor, FL, United States
Products
Destino Twist 14F (also branded as Guidestar 14F)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0646-2022Don't want to check this manually?
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