Recall Z-2249-2023— Creganna Medical Devices

Name: FDA recall Z-2249-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-22

Class II · Ongoing

Class II FDA medical device recall by Creganna Medical Devices, initiated 2023-06-22. It names one FDA 510(k) clearance: K152913. Product: Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access. Reason: Three lots of product may be labeled with an incorrect expiration day.

Recalling firm: Creganna Medical Devices
Classification: Class II
Status: Ongoing
Initiated: 2023-06-22
Firm location: Galway, N/A, Ireland

510(k) clearances named in this recall

1 on FDA's record

K152913 — GORE TIPS Set, GORE TIPS Sheath, GORE TIPS NeedleCreganna Medical Aslo Business AS Cregganna Tactx Medical·cleared 2016-07-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Three lots of product may be labeled with an incorrect expiration day

Data sourced from openFDA. This site is unofficial and independent of the FDA.