Medical device recalls Moderate risk

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

Recall date
October 1, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0473-2019
FDA classification
Class II
Brand / firm
LeMaitre Vascular, Inc.
Sold / distributed
FL Foreign: Austalia, Korea

Why it was recalled

Pouches from this lot are not sealed compromising the sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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