FDA recall Z-0411-2020

Angiodynamics Inc. (Navilyst Medical Inc.) · Class II · device

Product

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.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2019-10-02
Report date: 2019-11-27
Termination date: 2020-07-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Glens Falls, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0411-2020