Gore Tips Set Device recall
Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
Why was Gore Tips Set Device recalled?
Three lots of product may be labeled with an incorrect expiration day
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI/DI 05391526210000, Lot Numbers: 1V00099635, 1V00166928, 1V00199622
- Product
- Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
- Recalling firm
- Creganna Medical Devices
- Quantity
- 194 units
- Distribution
- US Nationwide distribution in the state of AZ.
- Recall date
- August 9, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)