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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