FDA Enforcement
Class II
Terminated
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: Z-0643-2019
·
Reported December 26, 2018
Enforcement
- Recall Number
- Z-0643-2019
- Event ID
- 81537
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Theragenics Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- December 26, 2018
- Initiation Date
- October 9, 2018
- Classification Date
- December 19, 2018
- Termination Date
- August 18, 2020
- Address
- 5203 Bristol Industrial Way, Buford, GA, 30518-1799, United States
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
Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed
Code Info
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
Nationwide distribution to FL, CA, AL, DE, NC, TX, UT, MS. International distribution to South Africa.
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.