PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: November 28, 2018 Initiated: October 1, 2018 #Z-0473-2019

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

Details

Recalling Firm
LeMaitre Vascular, Inc.
Units Affected
46 units
Distribution
FL Foreign: Austalia, Korea
Location
Burlington, MA

Frequently Asked Questions

What product was recalled?
LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10. Recalled by LeMaitre Vascular, Inc.. Units affected: 46 units.
Why was this product recalled?
Pouches from this lot are not sealed compromising the sterility
Which agency issued this recall?
This recall was issued by the FDA Devices on November 28, 2018. Severity: Moderate. Recall number: Z-0473-2019.