FDAFDA · Food and drugs·Recall number Z-0482-2015
Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose of improving intracranial perfusion.
Published December 10, 2014 · Recall initiated: October 22, 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
Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Neurovascular
- Distributor
- US Distribution to the states of: VA, NH, OH and TX.
- Lot
- Model M00320072209270, Lot number: 12693091; Exp. Jun 2012.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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