Reported Dec 26, 2018 · Terminated

Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic…

Theragenics Corporation

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: Theragenics Corporation · 5203 Bristol Industrial Way · Buford, GA · 30518-1799

Is this the product you have?

  • Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and the hollow steel needle.
Lot codes and dates
    • Box part number CPPS-MN-1820
    • Multipack part number CPPS-MN-1820-5
  • UDI(01)00813787021515(10)18090480(11)180904(17)220831; Lot # 180904-80
Amount recalled
480 packs (5 needles each)  NOTE: The multipacks are part of a box of 25 needles, containing five (5) single packs and four (4) 5-packs.

Where it was sold

Why it was recalled

Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed

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 Aug 18, 2020 · Data as of Sep 19, 4:46 PM UTC

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