Reported Aug 9, 2023 · Ongoing

Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access

Creganna Medical Devices

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: Creganna Medical Devices · Parkmore House · Galway, N/A · N/A

Is this the product you have?

  • Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
Lot codes and dates
  • UDI/DI 05391526210000
  • Lot Numbers
    • 1V00099635
    • 1V00166928
    • 1V00199622
Amount recalled
194 units

Where it was sold

  • Nationwide
  • AZ

Why it was recalled

Three lots of product may be labeled with an incorrect expiration day

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

Data as of Sep 19, 6:49 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.