FDAClass IIDecember 10, 2014

GDC-10 360 10mm x 30cm SR recall

GDC-10 360 10mm x 30cm SR ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology…

Why was GDC-10 360 10mm x 30cm SR recalled?

Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model M0033461030SRO, Lot number: 13239506; Exp. Jan 2013.

Product
GDC-10 360 10mm x 30cm SR ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology…
Recalling firm
Stryker Neurovascular
Quantity
1 unit
Distribution
US Distribution to the states of: VA, NH, OH and TX.
Recall date
December 10, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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