Angiodynamics Inc. (Navilyst Medical Inc.) recalls Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi…

Recall date

October 2, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0411-2020

FDA classification

Class II

Brand / firm

Angiodynamics Inc. (Navilyst Medical Inc.)

Sold / distributed

The products were distributed to the following US states: LA, MA, OR, VA, and WA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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