Theragenics Applicator Needle (18g x 20cm) recallZ-0643-2019 · Theragenics Corporation · initiated Oct 9, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Theragenics Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed
FDA root cause category: Under Investigation by firm
What the company is doing
Theragenics notified customers on about 10/09/2018 via phone call and follow up email. Instructions included to return any affected product to Theragenics for replacement.
Recall details
- Recall number
- Z-0643-2019
- Status
- Terminated
- Initiated by the company
- Oct 9, 2018
- Recalling firm
- Theragenics Corporation
- Quantity
- 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.
- Product code
- IWJ
- Distribution
- Nationwide distribution to FL, CA, AL, DE, NC, TX, UT, MS. International distribution to South Africa.
Product description
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.
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Theragenics CPPS-MN-1820-5Theragenics Corporation · System, Applicator, Radionuclide, Manual1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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