FDA recall Z-0418-2021

Product

Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H787065970355

Reason for recall

5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component

Distribution

US Nationwide distribution including in the states of AL, CT, GA, FL.

Key facts

Status

Terminated

Initiation date

2020-10-14

Report date

2020-11-11

Termination date

2021-10-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Queensbury, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0418-2021