Recall Z-0473-2019— LeMaitre Vascular, Inc.

Name: FDA recall Z-0473-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-01

Class II · Terminated

Class II FDA medical device recall by LeMaitre Vascular, Inc., initiated 2018-10-01, terminated 2020-04-10. It names one FDA 510(k) clearance: K152833. Product: LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10. Reason: Pouches from this lot are not sealed compromising the sterility.

Recalling firm: LeMaitre Vascular, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-10-01
Terminated: 2020-04-10
Firm location: Burlington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K152833 — Pruitt F3-S Polyurethane Carotid ShuntLeMaitre Vascular, Inc.·cleared 2016-01-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.