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U.S. Department of Health and Human Services

Class 1 Device Recall FindrWIRZ Guidewire System

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  Class 1 Device Recall FindrWIRZ Guidewire System see related information
Date Initiated by Firm September 29, 2016
Date Posted November 09, 2016
Recall Status1 Terminated 3 on March 01, 2017
Recall Number Z-0328-2017
Recall Event ID 75395
510(K)Number K080364  
Product Classification Wire, guide, catheter - Product Code DQX
Product FindrWIRZ Guidewire System Catalog# 40-05

Cardiology:
The system is intended for use in the cardiovascular system for
introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures.
Code Information Lot# 01160568 . Lot#02160586, (no products shipped from this lot) Lot# 07160639 -150 
Recalling Firm/
Manufacturer		 SentreHeart Inc
300 Saginaw Dr
Redwood City CA 94063-4743
For Additional Information Contact Robert Strasser
650-241-6008
Manufacturer Reason
for Recall		 A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking of the PTFE lubricious coating on three FindrWIRZ Guidewire System .025 guidewires removed from their packaging hoops.
FDA Determined
Cause 2		 Under Investigation by firm
Action SentreHeart sent an Urgent Medical Device Voluntary Recall letter dated September 29, 2016, to all affected customers by traceable delivery method. Letters explained the issue and requested that any devices from the two affected lots be returned to SentreHEART immediately. Customers were asked to complete and return the enclosed response form as soon as possible via fax at 650-354-1204 or email to customerservice@sentreheart.com. Customers with questions were instructed to call 1-855-256-7330. For questions regarding this recall call 650-241-6008.
Quantity in Commerce 132 worldwide distribution (98) of those units in US
Distribution Worldwide Distribution - US including MO, CA, OR, GA. NH, NY, MI, TX, MD, PA, IL, KS, NE, CT, AZ and Internationally to United Kingdom and Germany
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.
510(K) Database 510(K)s with Product Code = DQX and Original Applicant = SENTREHEART INC.
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