Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81537

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 09, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Theragenics Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0643-2019
Recall number
Z-0643-2019
Initiated
October 09, 2018
Classification
Class II
Status
Terminated
Recalling firm
Theragenics Corporation
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.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

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.