Home / Recalls / Angiodynamics Inc. (Navilyst Medical Inc.) / Z-0411-2020

Z-0411-2020 Class II Terminated

Recalled by Angiodynamics Inc. (Navilyst Medical Inc.) — Glens Falls, NY

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

Other recalls by Angiodynamics Inc. (Navilyst Medical Inc.)

  • Z-1467-2021 Class II — AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer (February 22, 2021)
  • Z-1466-2021 Class II — Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product U (February 22, 2021)
  • Z-0502-2020 Class II — BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - (September 18, 2019)
  • Z-0504-2020 Class II — BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022 (September 18, 2019)
  • Z-0503-2020 Class II — BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED, UPN H965440210, Cat. No. 44-021 - P (September 18, 2019)
  • Z-0501-2020 Class II — BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - P (September 18, 2019)
  • Z-0505-2020 Class II — XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040 - (September 18, 2019)
  • Z-1700-2019 Class II — AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator (April 17, 2019)
  • Z-1701-2019 Class II — AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Gene (April 17, 2019)
  • Z-1702-2019 Class II — AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applica (April 17, 2019)