Reported Jan 15, 2020 · Terminated

Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303

Abbott Medical

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: Abbott Medical · 5050 Nathan Ln N · Plymouth, MN · 55442-3209

Is this the product you have?

    • Fast-Cath Trio HEMOSTASIS INTRODUCER
    • 14F
    • 4.6 mm
    • REF 406303
Lot codes and dates
  • UDI(01)15414734203903(17)220731(10)7133555
  • Batch7133555
Amount recalled
814 devices

This recall covers 2 products

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

Where it was sold

Why it was recalled

Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.

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 Dec 14, 2020 · Data as of Sep 19, 6:57 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.