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U.S. Department of Health and Human Services

Class 3 Device Recall IntraCoil

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 Class 3 Recall
IntraCoil
see related information
Date Posted September 21, 2008
Recall Status1 Terminated on May 27, 2009
Recall Number Z-1816-2008
Recall Event ID 48102
Premarket Approval
PMA Number
P000033
Product Classification Stent, Superficial Femoral Artery - Product Code NIP
Product ev3 The Endovascular Company, IntraCoil Self-Expanding Peripheral Stent, Model REF VT-6-60-135, Lot 4401214, Use Before 2010-07.
Code Information Lot 4401214
Recalling Firm/
Manufacturer
Ev3, Inc
4600 Nathan Ln N
Plymouth, Minnesota 55442-2890
Manufacturer Reason
for Recall
An IntraCoil 6 mm x 40 mm stent was labeled as a 6 mm x 60 mm stent.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action ev3 representative visited the consignee on 4/15/08 and spoke to the physician at the site that used the device. A Device Recall Field Action Reconcilliation Form was requested.
Quantity in Commerce 1
Distribution CA
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = NIP and Applicant = EV3 INC
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