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U.S. Department of Health and Human Services

Class 2 Device Recall LeMaitre Vascular

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 Class 2 Device Recall LeMaitre Vascularsee related information
Date Initiated by FirmOctober 01, 2018
Create DateNovember 16, 2018
Recall Status1 Terminated 3 on April 10, 2020
Recall NumberZ-0473-2019
Recall Event ID 81391
510(K)NumberK152833 
Product Classification Catheter, intravascular occluding, temporary - Product Code MJN
ProductLeMaitre Vascular Pruitt F3-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
Code Information LOT# PFP1055 Expiration Date: 2020-03-28
FEI Number 1220948
Recalling Firm/
Manufacturer		 LeMaitre Vascular, Inc.
63 2nd Ave
Burlington MA 01803-4413
For Additional Information ContactRose Lerer
781-425-1671
Manufacturer Reason
for Recall		Pouches from this lot are not sealed compromising the sterility
FDA Determined
Cause 2		Packaging process control
ActionLemaitre Vascular initiated recall by letter on October 1, 2018, provided with reason for recall action to be taken, risk to health. Complete the enclosed customer reply form, and return it to LeMaitre Vascular, Inc. Return all devices from lot PFP1055, whether they appear to be unsealed or not. If you distributed any affected product to other facilities, please forward this recall to the recipients. Contact Information: rlerer@lemaitre.com 781-425-1671 Monday through Friday, 8:00 AM to 4:30 PM,
Quantity in Commerce46 units
DistributionFL Foreign: Austalia, Korea
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MJN
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