NewDeal SA recalls ADVANSYS TTC models 181001S-181014S due to risk of infection requiring antibiotics or device removal. Affected units sold with specific lot numbers.
Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.
NewDeal SA is recalling several ADVANSYS TTC models because using them may cause infections that need antibiotics or device removal. This is serious but not life-threatening under normal use.
The device can cause minor wounds that become infected, leading to serious infections requiring antibiotics or removal of the device. This happens when the device is used improperly or if the skin is broken.
Users of the recalled ADVANSYS TTC models are most at risk if they have open wounds or cuts. People with compromised immune systems may face higher infection risks.
Check your ADVANSYS TTC device for model numbers 181001S through 181014S. Look for specific lot numbers listed in the recall notice for each model.
Identify your ADVANSYS TTC model number by checking the device label.
Reach out to NewDeal SA for assistance with the recall process.
No, the recall does not require immediate stop use. However, if you have an open wound, contact NewDeal SA for advice.
The recall states that minor wounds may become infected, so monitor for signs of infection and contact NewDeal SA if needed.
Check your device model number against the list of affected models (181001S-181014S) and lot numbers provided in the recall notice.
We’ve drafted a message you can send NewDeal SA to request your refund or repair — edit it as you like.
Subject: Recall Z-2444-2018 — NewDeal SA NewDeal SA Hello, I own a NewDeal SA that is covered by recall Z-2444-2018 from NewDeal SA. 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.
