LeMaitre Vascular, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0473-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 1, 2018

Date Posted: November 28, 2018

Recall Number: Z-0473-2019

Event ID: 81391

Reason for Recall:

Pouches from this lot are not sealed compromising the sterility

Status: Terminated

Product Quantity: 46 units

Code Information:

LOT# PFP1055 Expiration Date: 2020-03-28

Distribution Pattern:

FL Foreign: Austalia, Korea

Voluntary or Mandated:

Voluntary: Firm initiated