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
|