Device 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.
Z-0643-2019
Product summary
- Event
- Event 81537
- Status
- Terminated
- Classification
- Class II
- 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.
- Official record key
device-enforcement:Z-0643-2019
Official wording
Reason: 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.
Derived failure modes
-
Unknown
Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed