Reported Jun 14, 2017 · Terminated

Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G…

Argon Medical Devices, 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: Argon Medical Devices, Inc · 1445 Flat Creek Rd · Athens, TX · 75751-5002

Is this the product you have?

    • Clear Flashback Needle 7cm x 18G AMC/4
    • Clear Flashback Needle 2.5 cm x 21G AMC/4
    • Winged Arterial Needle 7cm x 18G AMC/4
    • Clear
  • Flashback Needle 7 cm x 19G AMC/4 UsageArgon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of a guidewire
Lot codes and dates
  • 11161099 11161729 11160990 11160912
Amount recalled
7140 pieces

Where it was sold

  • Nationwide

Why it was recalled

Argon Medical has received a complaint from one of their distributors of a potential packaging defect. The product is sealed in a pouch and the defect if present shows as a potential void or unsealed edge of the pouch.

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 Jan 25, 2018 · Data as of Sep 19, 4:44 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.