Recall Z-0643-2019 ยท IWJ System, Applicator, Radionuclide, Manual
Theragenics Corporation
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.
| Date | Oct 9, 2018 |
| Status | Terminated |
| Reason | Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 480 packs (5 needles each) NOTE: The multipacks are part of a box of 25 needles, containing five (5) single packs and |
| Distribution | Nationwide distribution to FL, CA, AL, DE, NC, TX, UT, MS. International distribution to South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.