Gore Tips Set Device (Creganna Medical) – Incorrect Expiration Label (2023)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
Brand
Creganna Medical Devices Parkmore House Mweeloon Galway Ireland
Lot Codes / Batch Numbers
UDI/DI 05391526210000, Lot Numbers: 1V00099635, 1V00166928, 1V00199622
Products Sold
UDI/DI 05391526210000, Lot Numbers: 1V00099635, 1V00166928, 1V00199622
Creganna Medical Devices Parkmore House Mweeloon Galway Ireland is recalling Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access due to Three lots of product may be labeled with an incorrect expiration day. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Three lots of product may be labeled with an incorrect expiration day
Recommended Action
Per FDA guidance
Creganna Medical notified its sole consignee on 06/22/2023 via email. The notice explained the problem with the product and informed the consignee of their intention to collaboratively conduct a recall. The sole consignee is notifying their customers by letter delivered by FedEX on 06/28/2023. The product is to be returned to the consignee.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026