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U.S. Department of Health and Human Services

Class 2 Device Recall Zilver 518 Vascular Self Expanding Stent

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 Class 2 Recall
Zilver 518 Vascular Self Expanding Stent
see related information
Date Posted September 01, 2012
Recall Status1 Terminated on February 04, 2013
Recall Number Z-2309-2012
Recall Event ID 61451
Premarket Approval
PMA Number
P050017
Product Classification Stent, Iliac - Product Code NIO
Product Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.
Code Information Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014
Recalling Firm/
Manufacturer
Cook Ireland Ltd.
O'holloran Road,
National Technological Park
Limerick, Peroc
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Rita Harden
800-346-2686 Ext. 2222
Manufacturer Reason
for Recall
Cook Ireland received a product complaint from Japan on December 22nd, 2011. The complainant reported that a 5 French Zilver Vascular Stent (part number ZIV5-18-125-8-80 from Lot# CF694429) was inserted into a sheath over a wire guide where it became lodged in the sheath hub. After further examination, the user determined that the product was a 6 French Zilver Vascular Stent (part number ZIV6-35
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
Action The firm, Cook Medical, sent a letter dated February 13, 2012 to foreign consignee. The letter described the product, problem and actions taken. The firm stated that re-training of the relevant personnel has been carried out; they will continue to monitor to identify potential emerging trends and further corrective and preventive action will be considered in an effort to avoid the recurrence of similar events. If you have any question contact in US: Customer Relations Manager at 800.346.2686.ext 2222 or email: rita.harden@cookmedical.com; OUS: Customer Quality Supervisor at +353 61 239343.
Quantity in Commerce 15 units of ZIV5-18-125-8-80 LOT# CF694429
Distribution Worldwide distribution: USA (nationwide) and country of: Japan.
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 = NIO and Applicant = COOK INCORPORATED
PMAs with Product Code = NIO and Applicant = COOK MEDICAL INCORPORATED
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