Medical device recalls Moderate risk

Creganna Medical Devices recalls Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access

Recall date
June 22, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2249-2023
FDA classification
Class II
Brand / firm
Creganna Medical Devices
Sold / distributed
US Nationwide distribution in the state of AZ.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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