FDA Recall
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
·
Initiated October 9, 2018
Recall
- Recall Number
- Z-0643-2019
- Event Number
- 81537
- Firm
- Theragenics Corporation
- FEI Number
- 1037598
- Product Code
- IWJ
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- October 9, 2018
- Terminated
- August 18, 2020
- Address
- 5203 Bristol Industrial Way, Buford, GA, 30518-1799
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
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.
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.