FindrWIRZ Guidewire System recall
FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of…
Why was FindrWIRZ Guidewire System recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot# 01160568 . Lot#02160586, (no products shipped from this lot) Lot# 07160639 -150
- Product
- FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of…
- Recalling firm
- SentreHeart Inc
- Quantity
- 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
- Recall date
- November 16, 2016
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)