Theragenics Corporation: Medical Device Recall in 2018 - (Recall #: Z-0643-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 9, 2018

Date Posted: December 26, 2018

Recall Number: Z-0643-2019

Event ID: 81537

Reason for Recall:

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

Status: Terminated

Product Quantity: 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.

Code Information:

Box part number CPPS-MN-1820; Multipack part number CPPS-MN-1820-5; UDI: (01)00813787021515(10)18090480(11)180904(17)220831; Lot # 180904-80

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated