Z-0643-2019 Class II Terminated
FDA device recall Z-0643-2019 was initiated by Theragenics Corporation on October 9, 2018 and is designated Class II. Reason for recall: Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed The recall status is terminated (terminated August 18, 2020). Affected quantity: 480 packs (5 needles each) NOTE: The multipacks are part of a box of 25 needles, containing five (5) single packs and.
Recall Details
- Product Type
- Devices
- Report Date
- December 26, 2018
- Initiation Date
- October 9, 2018
- Termination Date
- August 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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.
Product Description
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.
Reason for Recall
Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed
Distribution Pattern
Nationwide distribution to FL, CA, AL, DE, NC, TX, UT, MS. International distribution to South Africa.
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