HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model HPSS35180- all lots.
- 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:
- Nitinol Devices and Components, Inc.
- Reason for Recall:
- Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
Product Codes/Lot Numbers:
Model HPSS35180- all lots.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1822-2014
Related Recalls
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.