Home / Recalls / Medical Devices
Theragenics Corporation recalls Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic ha
Recalled December 26, 2018 · FDA recall Z-0643-2019 · Theragenics
Hazard
Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed · FDA Class II
Units
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.
Sold at
Nationwide distribution to FL, CA, AL, DE, NC, TX, UT, MS. International distribution to South Africa.
Description
Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed
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.
Manufacturer(s)
Theragenics Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →