FDA-Device2023-08-09Class II

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

Creganna Medical Devices
Hazard

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

Sold states
US Nationwide distribution in the state of AZ.
Affected count
194 units
Manufactured in
Parkmore House, Mweeloon, Galway, N/A, Ireland
Products
Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2249-2023

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