FDA recall Z-2109-2020

Product

Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle puncture and tissue dilation with subsequent positioning of a guidewire for catheter placement in non-vascular procedures.

Reason for recall

Tungsten coils of the guidewire included in the introducer kit were detaching.

Distribution

International distribution to the countries of China, Taiwan.

Key facts

Status

Terminated

Initiation date

2020-04-26

Report date

2020-06-03

Termination date

2022-12-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Athens, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2109-2020