Medical device recalls Moderate risk

Sirtex Medical Limited recalls SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.

Recall date
February 22, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1275-2021
FDA classification
Class II
Brand / firm
Sirtex Medical Limited
Sold / distributed
US Nationwide distribution.

Why it was recalled

There is a potential presence of particulate matter in the D-Vial.

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

What was recalled

SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.

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