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U.S. Department of Health and Human Services

Class 2 Device Recall LeMaitre

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  Class 2 Device Recall LeMaitre see related information
Date Initiated by Firm February 07, 2017
Create Date March 13, 2017
Recall Status1 Terminated 3 on September 20, 2019
Recall Number Z-1452-2017
Recall Event ID 76476
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU)
REF# e2401-53
Code Information Lot Number/Exp. Date: RST2392 2018-09 RST2400 2018-10 RST2408 2018-12 RST2419 2019-04 RST2431 2019-04 RST2436 2019-05 RST2447 2019-08
Recalling Firm/
Manufacturer		 LeMaitre Vascular, Inc.
63 2nd Ave
Burlington MA 01803-4413
For Additional Information Contact
781-221-2266
Manufacturer Reason
for Recall		 The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
FDA Determined
Cause 2		 Labeling design
Action LeMaitre Vascular, Inc. issued a Dear Doctor letter, on 2/7/17, to distributors and hospitals via FedEx overnight. The letter contains a form that is requested to be returned to LeMaitre Vascular, Inc. as a record of notification and reconciliation. Any unused product requested to be returned and replaced. Questions concerning this notice contact 781-221-2266 ext. 183.
Quantity in Commerce 2065
Distribution Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
Total Product Life Cycle TPLC 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.
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