Medical device recalls Moderate risk

Angiodynamics, Inc. recalls Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 Ang…

Recall date
September 22, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0742-2018
FDA classification
Class II
Brand / firm
Angiodynamics, Inc.
Sold / distributed
US Distribution to the states of : AL, CA, CT, FL, GA, IL, IN, MD, MI, MN, MO, OH, OR, TX.

Why it was recalled

Product was placed into distribution prior to completion of all required post sterilization release activities.

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

What was recalled

Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.

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