Z-0328-2017 Class I Terminated
FDA device recall Z-0328-2017 was initiated by SentreHeart Inc on September 29, 2016 and is designated Class I. 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 remove… The recall status is terminated (terminated March 1, 2017). Affected quantity: 132 worldwide distribution (98) of those units in US.
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