Medical device recalls Moderate risk

Medtronic Vascular recalls Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35

Recall date
January 15, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1245-2021
FDA classification
Class II
Brand / firm
Medtronic Vascular
Sold / distributed
Nationwide

Why it was recalled

Sterility may be compromised due to an unsealed pouch

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

What was recalled

Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35

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