Reported Nov 16, 2016 · Terminated
FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for…
SentreHeart Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SentreHeart Inc · 300 Saginaw Dr · Redwood City, CA · 94063-4743
Is this the product you have?
- FindrWIRZ Guidewire System Catalog# 40-05
- CardiologyThe system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures
- Lot codes and dates
- Lot# 01160568 . Lot#02160586, (no products shipped from this lot) Lot# 07160639 -150
- Amount recalled
- 132 worldwide distribution (98) of those units in US
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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