Medical device recalls Moderate risk

Oscor, Inc. recalls AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various typ…

Recall date
March 10, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1329-2021
FDA classification
Class II
Brand / firm
Oscor, Inc.
Sold / distributed
US Nationwide distribution in the state of New York.

Why it was recalled

Potential for open seal on sterile product

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

What was recalled

AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.

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