FDA-Device2018-12-26Class II
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.
Theragenics Corporation
Hazard
Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed
Sold states
Nationwide distribution to FL, CA, AL, DE, NC, TX, UT, MS. International distribution to South Africa.
Affected count
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.
Manufactured in
5203 Bristol Industrial Way, Buford, GA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0643-2019Don't want to check this manually?
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