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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot# 01160568 . Lot#02160586, (no products shipped from this lot) Lot# 07160639 -150
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- SentreHeart Inc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Lot# 01160568 . Lot#02160586, (no products shipped from this lot) Lot# 07160639 -150
Distribution:
Distributed in: US, MO, CA, OR, GA, NH, NY, MI, TX, MD, PA, IL, KS, NE, CT, AZ
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0328-2017