Recall Z-0646-2022— Oscor Inc.

Name: FDA recall Z-0646-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-22

Class II · Completed

Class II FDA medical device recall by Oscor Inc., initiated 2021-12-22. It names one FDA 510(k) clearance: K140406. Product: Destino Twist 14F (also branded as Guidestar 14F). Reason: There is potential for separation between the threaded hub and threaded cap at the proximal end of the device..

Recalling firm: Oscor Inc.
Classification: Class II
Status: Completed
Initiated: 2021-12-22
Firm location: Palm Harbor, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K140406 — DESTINO TWIST, STEERABLE GUIDING SHEATHOscor, Inc.·cleared 2014-04-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.