Buford, GA, United States
Theragenics Corporation recalls
1 recall recorded since 2018, most recently on 9 October 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 9 October 2018
- Terminated
- 18 August 2020
- Reason
- Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed
- Distribution
- Nationwide distribution to FL, CA, AL, DE, NC, TX, UT, MS. International distribution to South Africa.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0643-2019
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.