Reported Mar 7, 2018 · Terminated

Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201…

Angiodynamics, Inc.

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: Angiodynamics, Inc. · 603 Queensbury Ave · Queensbury, NY · 12804-7619

Is this the product you have?

  • Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG
  • Catalog Number10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated
Lot codes and dates
  • Lot Number
    • 5229642
    • Manufactured 6-Sep-17
  • Expiration Date31-Aug-20
Amount recalled
28

Where it was sold

Why it was recalled

Product was placed into distribution prior to completion of all required post sterilization release activities.

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 Sep 19, 2018 · Data as of Sep 19, 5:31 PM UTC

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