FDA recall Z-0473-2019

Product

LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10

Reason for recall

Pouches from this lot are not sealed compromising the sterility

Distribution

FL Foreign: Austalia, Korea

Key facts

Status

Terminated

Initiation date

2018-10-01

Report date

2018-11-28

Termination date

2020-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Burlington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0473-2019