Reported Jan 18, 2023 · Ongoing

Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical,…

Stradis Healthcare

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: Stradis Healthcare · 3600 Burwood Dr · Waukegan, IL · 60085-8399

Is this the product you have?

  • Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Lot codes and dates
  • Assembly Number TM.FFTK
  • UDI-DIM752TMFFTK0
  • Lot Numbers
    • 220954416
    • 222418904
    • 221056552
    • 220070456
    • 220400116
    • 220411513
    • 220952568
    • 220943346
    • 221727862
    • 222709611
    • 222701385
Amount recalled
1,175 units

This recall covers 18 products

The agency filed one notice per product. You are reading one of them; the other 17 are below.

5 more are in the archive.

Where it was sold

Why it was recalled

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

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

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:21 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.