FDA recall Z-0646-2022

Product

Destino Twist 14F (also branded as Guidestar 14F)

Reason for recall

There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.

Distribution

Distribution to TN and PA in USA OUS distribution to Czech Republic

Key facts

Status

Completed

Initiation date

2021-12-22

Report date

2022-02-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Palm Harbor, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0646-2022