Gateway OTW 2.75mm x 9mm recall
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…
Why was Gateway OTW 2.75mm x 9mm 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 M00320072209270, Lot number: 12693091; Exp. Jun 2012.
- Product
- 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…
- 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)