FDA Medical Device Recalls (openFDA)
Theragenics Corporation: 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.
- Recall number
- Z-0643-2019
- Recalling firm
- Theragenics Corporation
- 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.
- Status
- Terminated
- Initiated
- 2018-10-09
- Posted
- not on file
- Terminated
- 2020-08-18
- Reason
- Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IWJ
- Firm FEI
- 1037598
- Firm city
- Buford
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28