Reported Mar 24, 2021 · Terminated

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

Sirtex Medical Limited

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Sirtex Medical Limited · Centrecourt Business Park, · North Ryde, New South Wales, N/A · N/A

Is this the product you have?

  • SIROS D-Vial Prep Set
  • Product Code SIR-10200 - Product Usageintended for single use
Lot codes and dates
  • Lot Numbers
    • 1031234
    • 1031225
    • 1031227
    • 1031229
Amount recalled
3310

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 17, 2023 · Data as of Sep 19, 6:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.