NewDeal SA recalls ADVANSYS MLP/DLP models 181021S-181052S with specific lot numbers due to risk of infection requiring antibiotics or device removal.
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 specific models of ADVANSYS MLP/DLP devices because they can cause infections that need antibiotics or surgical intervention. This matters because infections can become serious if not treated properly.
The recalled devices may cause infections that start as superficial wounds requiring oral antibiotics but can become deep infections needing intravenous antibiotics and device removal. This happens due to potential contamination during use.
Users of the recalled ADVANSYS MLP/DLP devices with the listed model numbers and lot numbers are affected. People who have these devices and use them for medical purposes are most at risk.
Check your device's model number (181021S through 181052S) and lot number against the list provided in the recall notice. The devices were sold with specific lot numbers listed for each model.
Identify your device's model number (181021S-181052S) and lot number to see if it matches the recalled list.
The recall does not require immediate stoppage; however, you should check if your device is affected before continuing use.
The recall covers specific model numbers (181021S through 181052S) and lot numbers; other models are not affected.
The risk can lead to superficial infections needing oral antibiotics or deep infections requiring IV antibiotics and device removal.
We’ve drafted a message you can send NewDeal to request your refund or repair — edit it as you like.
Subject: Recall Z-2445-2018 — NewDeal NewDeal Hello, I own a NewDeal that is covered by recall Z-2445-2018 from NewDeal. 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.
