Z-0411-2020 Class II Terminated
FDA device recall Z-0411-2020 was initiated by Angiodynamics Inc. (Navilyst Medical Inc.) on October 2, 2019 and is designated Class II. Reason for recall: The devices are not labelled correctly. End users impacted by this issue may experience a procedural delay. The recall status is terminated (terminated July 29, 2020). Affected quantity: 30.
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2019
- Initiation Date
- October 2, 2019
- Termination Date
- July 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30
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.
Distribution Pattern
The products were distributed to the following US states: LA, MA, OR, VA, and WA.
Code Information
Lot 5476032