Recall Z-0643-2019— Theragenics Corporation
Class II · Terminated
Class II FDA medical device recall by Theragenics Corporation, initiated 2018-10-09, terminated 2020-08-18. FDA's recall record names no specific 510(k) clearance for this event. 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.
- Recalling firm
- Theragenics Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-10-09
- Terminated
- 2020-08-18
- Firm location
- Buford, GA, United States
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.
Reason for recall
Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed
Data sourced from openFDA. This site is unofficial and independent of the FDA.