FDA-Device2021-03-24Class II

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

Sirtex Medical Limited
Hazard

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

Sold states
US Nationwide distribution.
Affected count
3310
Manufactured in
Centrecourt Business Park,, Unit D4, 25-27, Paul Street North, North Ryde, New South Wales, N/A, Australia
Products
SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1275-2021

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