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U.S. Department of Health and Human Services

Class 2 Device Recall Theragenics Brachytherapy needles

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 Class 2 Device Recall Theragenics Brachytherapy needlessee related information
Date Initiated by FirmOctober 09, 2018
Create DateDecember 19, 2018
Recall Status1 Terminated 3 on August 18, 2020
Recall NumberZ-0643-2019
Recall Event ID 81537
Product Classification System, applicator, radionuclide, manual - Product Code IWJ
ProductTheragenics 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.
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
FEI Number 1037598
Recalling Firm/
Manufacturer		 Theragenics Corporation
5203 Bristol Industrial Way
Buford GA 30518-1799
For Additional Information ContactBetsy Cortelloni
770-831-4294
Manufacturer Reason
for Recall		Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed
FDA Determined
Cause 2		Under Investigation by firm
ActionTheragenics 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.
Quantity in Commerce480 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.
DistributionNationwide distribution to FL, CA, AL, DE, NC, TX, UT, MS. International distribution to South Africa.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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