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-1820Multipack 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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