Z-0328-2017 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 16, 2016
- Initiation Date
- September 29, 2016
- Termination Date
- March 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 132 worldwide distribution (98) of those units in US
Product Description
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.
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.
Distribution Pattern
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
Code Information
Lot# 01160568 . Lot#02160586, (no products shipped from this lot) Lot# 07160639 -150