Theragenics Corporation recalls Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic hand…

Recall date

October 9, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0643-2019

FDA classification

Class II

Brand / firm

Theragenics Corporation

Sold / distributed

Nationwide distribution to FL, CA, AL, DE, NC, TX, UT, MS. International distribution to South Africa.

Why it was recalled

Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.