FDA recall Z-0643-2019

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 for recall

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.

Key facts

Status

Terminated

Initiation date

2018-10-09

Report date

2018-12-26

Termination date

2020-08-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Buford, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0643-2019