Z-2249-2023Class II

Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access

Name: Z-2249-2023 Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
Creator: Creganna Medical Devices
Published: 2023-06-22
License: https://open.fda.gov/license/

Creganna Medical Ireland Limited / initiated 2023-06-22 / Open, Classified / root cause: manufacturing process

FDA source

Creganna Medical Devices began a recall of Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access on 2023-06-22. FDA classified it as Class II and gives the reason as "Three lots of product may be labeled with an incorrect expiration day". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2249-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-22
Posted: 2023-07-28
Recalling firm: Creganna Medical Ireland Limited
Product: Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
Product code: DYB Introducer, Catheter
Reason for recall: Three lots of product may be labeled with an incorrect expiration day
Root cause tag: manufacturing process
FDA 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 in commerce: 194 units
Distribution: US Nationwide distribution in the state of AZ.
Product codes and lots: UDI/DI 05391526210000, Lot Numbers: 1V00099635, 1V00166928, 1V00199622

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2249-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2249-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-28

Product code DYB

K152913Class IIGORE TIPS Set, GORE TIPS Sheath, GORE TIPS NeedleCreganna Medical Aslo Business AS Cregganna Tactx Medical / cleared 2016-07-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)