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U.S. Department of Health and Human Services

Class 1 Device Recall Catheter, Introducer

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 Class 1 Recall
Catheter, Introducer
see related information
Date Posted June 07, 2013
Recall Status1 Terminated on August 19, 2013
Recall Number Z-1436-2013
Recall Event ID 65248
Premarket Notification
510(K) Number
K120212 
Product Classification Introducer, Catheter - Product Code DYB
Product Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.
Code Information Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845
Recalling Firm/
Manufacturer
Endologix Inc
11 Studebaker
Irvine, California 92618-2013
Manufacturer Reason
for Recall
Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Endologix Inc sent an "URGENT-MEDICAL DEVICE RECALL NOTICE" letters dated May 13, 2013 to all affected customers. The letter identified the affected product, reason for recall, and actions to be taken. The letter instructed customers to do not use or further distribute any affected product. The letter instructed customers to share this information with physicians that perform these procedures at the facility. The firm will call to confirm that this device is located at the facility. After confirmation the firm will retrieve the device. For questions call (800) 983-2284.
Quantity in Commerce 53
Distribution Worldwide Distribution - USA Nationwide in the states of: NY, NH, IN, MI, FL and NJ and in the countries of: Europe and Latin America.
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.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = ENDOLOGIX, INC.
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