Recalled Prevantics swabs (3.15% chlorhexidine gluconate) due to uncertainty in test method validation. Check NDC 10819-1080-1 or 10819-1080-2 for affected lots.
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Professional Disposables International is recalling Prevantics swabs because manufacturing test methods weren't validated properly. This could mean the swabs don't work as intended for medical use.
The swabs were manufactured using test methods that weren't properly validated. This uncertainty means the product might not work as intended for medical use, potentially affecting treatment effectiveness.
Healthcare professionals and medical facilities using the Prevantics swabs. Patients using these swabs for medical procedures may be at risk if the product doesn't function correctly.
Check for NDC codes 10819-1080-1 or 10819-1080-2 on the packaging. Look for specific lot numbers listed in the recall notice, which include dates from February 2022 through May 2023.
Look for the lot number on the packaging, which is listed in the recall notice for specific dates from February 2022 through May 2023.
The recall is due to uncertainty in the validation of test methods used during manufacturing, which could affect the product's intended medical use.
Check for NDC codes 10819-1080-1 or 10819-1080-2 on the packaging and look for specific lot numbers listed in the recall notice, which include dates from February 2022 through May 2023.
The recall notice does not specify a remedy, so contact the manufacturer directly for guidance.
We’ve drafted a message you can send Professional Disposables International to request your refund or repair — edit it as you like.
Subject: Recall D-0571-2022 — Professional Disposables International Professional Disposables International Hello, I own a Professional Disposables International that is covered by recall D-0571-2022 from Professional Disposables International. 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.
