Z-0643-2019Class II

Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with...

Name: Z-0643-2019 Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with...
Creator: Theragenics Corporation
Published: 2018-10-09
License: https://open.fda.gov/license/

Theragenics Corp. / initiated 2018-10-09 / Terminated / root cause: packaging

FDA source

Theragenics Corporation began a recall of 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... on 2018-10-09. FDA classified it as Class II and gives the reason as "Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0643-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-09
Posted: 2018-12-19
Terminated: 2020-08-18
Recalling firm: Theragenics Corp.
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.
Product code: IWJ System, Applicator, Radionuclide, Manual
Reason for recall: Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed
Root cause tag: packaging
FDA root cause: Under Investigation by 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.
Quantity in commerce: 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.
Distribution: Nationwide distribution to FL, CA, AL, DE, NC, TX, UT, MS. International distribution to South Africa.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0643-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0643-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-19

Product code IWJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)