FDAFDA · Food and drugs·Recall number Z-1820-2014
HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 260 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
Published July 2, 2014 · Recall initiated: May 28, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nitinol Devices and Components, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.
- Lot
- Model HPSA35260- all lots.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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