FDA Device recall Z-0643-2019
Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements
- FDA Device
- Class II
- terminated
- Published 2018-12-26
On 2018-12-26 the FDA classified a Class II recall of Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements by Theragenics, citing some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0643-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-09 |
| Published | 2018-12-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Theragenics |
| Distribution | US |
Product
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.
Reason
Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0643-2019%22
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