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Class 2 Device Recall LeMaitre |
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Date Initiated by Firm |
February 07, 2017 |
Create Date |
March 13, 2017 |
Recall Status1 |
Terminated 3 on September 20, 2019 |
Recall Number |
Z-1446-2017 |
Recall Event ID |
76476 |
Product Classification |
Catheter, intravascular, diagnostic - Product Code DQO
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Product |
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50 |
Code Information |
Lot Number/Ex p. Date: RST2390 2018-08 RST2393 2018-09 RST2396 2018-10 RST2397 2018-10 RST2398 2018-10 RST2401 2018-12 RST2402 2018-12 RST2418 2019-02 RST2420 2019-03 RST2423 2019-03 RST2428 2019-04 RST2432 2019-04 RST2433 2019-04 RST2437 2019-06 RST2438 2019-06 RST2441 2019-07 |
Recalling Firm/ Manufacturer |
LeMaitre Vascular, Inc. 63 2nd Ave Burlington MA 01803-4413
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For Additional Information Contact |
781-221-2266
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Manufacturer Reason for Recall |
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
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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 |
4673 |
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
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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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