FDA recall Z-1329-2021

Product

AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.

Reason for recall

Potential for open seal on sterile product

Distribution

US Nationwide distribution in the state of New York.

Key facts

Status

Terminated

Initiation date

2021-03-10

Report date

2021-04-07

Termination date

2023-08-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Palm Harbor, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1329-2021