FDAFDA · Food and drugs·Recall number Z-0478-2015
GDC-10 360 SOFT 3mm x 6cm SR ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable
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 M003347306SRO, Lot number: 14467382; Exp. May 2014.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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