Recall Z-0411-2020— Angiodynamics Inc. (Navilyst Medical Inc.)

Name: FDA recall Z-0411-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-02

Class II · Terminated

Class II FDA medical device recall by Angiodynamics Inc. (Navilyst Medical Inc.), initiated 2019-10-02, terminated 2020-07-29. It names one FDA 510(k) clearance: K010060. Product: Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151. Reason: The devices are not labelled correctly. End users impacted by this issue may experience a procedural delay..

Recalling firm: Angiodynamics Inc. (Navilyst Medical Inc.)
Classification: Class II
Status: Terminated
Initiated: 2019-10-02
Terminated: 2020-07-29
Firm location: Glens Falls, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K010060 — RITA STARBURST XLI ELECTROSURGICAL DEVICERita Medical Systems·cleared 2001-01-23

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

Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151

Reason for recall

The devices are not labelled correctly. End users impacted by this issue may experience a procedural delay.

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