Recall Z-0643-2019
Theragenics Corporation · initiated October 9, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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
Reason for recall
Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-0643-2019
- Initiated
- October 9, 2018
- Terminated
- August 18, 2020
- Product code
- IWJ – System, Applicator, Radionuclide, Manual
- 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.
- Recalling firm
- Theragenics Corporation, Buford, GA