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.
FDA Recall Z-0643-2019 · Posted None
Recalling FirmTheragenics Corporation
Recall StatusTerminated
Product CodeIWJ
Date Initiated2018-10-09
Date Terminated2020-08-18
Product Quantity480 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.
Reason for Recall
Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed
Firm Action
Theragenics notified customers on about 10/09/2018 via phone call and follow up email. Instructions included to return any affected product to Theragenics for replacement.
Root Cause
Under Investigation by firm
Distribution Pattern
Nationwide distribution to FL, CA, AL, DE, NC, TX, UT, MS. International distribution to South Africa.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.