FDA Medical Device Recalls (openFDA)
Creganna Medical Devices: Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
- Recall number
- Z-2249-2023
- Recalling firm
- Creganna Medical Devices
- Product
- Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
- Status
- Open, Classified
- Initiated
- 2023-06-22
- Posted
- 2023-07-28
- Terminated
- not on file
- Reason
- Three lots of product may be labeled with an incorrect expiration day
- Root cause
- Process control
- Action
- 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.
- Quantity
- 194 units
- Distribution
- US Nationwide distribution in the state of AZ.
- Lot, serial or model codes
- UDI/DI 05391526210000, Lot Numbers: 1V00099635, 1V00166928, 1V00199622
- 510(k) numbers
- ["K152913"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 3004193842
- Firm city
- Mweeloon Galway
- Firm state
- not on file
- Firm country
- Ireland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28