Theragenics recalls 18g x 20cm Applicator Needles due to unsealed pouches that may cause contamination. Affected units sold with lot #180904-80.
Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed
Theragenics is recalling 18g x 20cm Applicator Needles because some pouches weren't sealed properly. This could lead to contamination of the needles, which are used in medical brachytherapy treatments.
The needles are used in medical brachytherapy procedures. Unsealed pouches could allow contaminants to enter the needles, potentially causing infections or other complications during treatment.
Medical professionals using brachytherapy treatments with these needles are most at risk. Patients receiving treatments with these needles may also be affected.
Check for the product name 'Theragenics Applicator Needle (18g x 20cm)' on the packaging. Look for lot number 180904-80 on the box.
Inspect the pouches for proper sealing; unsealed pouches may indicate contamination risk.
The recall is due to some pouches containing the needles not being sealed properly, which could lead to contamination.
Look for the product name 'Theragenics Applicator Needle (18g x 20cm)' and lot number 180904-80 on the box.
The recall record does not specify a remedy, so contact Theragenics directly for guidance.
We’ve drafted a message you can send Theragenics to request your refund or repair — edit it as you like.
Subject: Recall Z-0643-2019 — Theragenics Theragenics Hello, I own a Theragenics that is covered by recall Z-0643-2019 from Theragenics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
