Professional Disposables International recalls Prevantics swabsticks due to uncertainty in test method validation during manufacturing. Affected products include specific lot numbers and packaging sizes. Consumers should check their product details to determine if they are affected.
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Professional Disposables International is recalling Prevantics swabsticks because of manufacturing quality concerns. The issue involves uncertainty in how test methods were validated during production, which could affect product safety.
The recall is due to uncertainty in the adequacy of test methods used to validate the manufacturing process. This could mean the product's effectiveness or safety might not meet expected standards, though it does not indicate immediate harm to users.
Users of Prevantics swabsticks with specific lot numbers and packaging sizes (one swabstick pouches, 50 or 500 swabsticks per case) are affected. Healthcare professionals and individuals using these products for medical purposes are most at risk.
Check the product packaging for the NDC code 10819-4077-1, 10819-4077-2, or 10819-4077-3. Look for specific lot numbers listed in the recall notice, such as 12000203, 12000204, or 12001114.
Review the product packaging for the NDC code and lot numbers listed in the recall notice to determine if your swabsticks are affected.
The recall is due to uncertainty in the adequacy of test methods used to validate the manufacturing process, which could affect product safety.
Affected products include Prevantics swabsticks with NDC codes 10819-4077-1, 10819-4077-2, or 10819-4077-3, and specific lot numbers listed in the recall notice.
The recall does not require immediate discontinuation; check the product details to determine if your swabsticks are affected.
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-0572-2022 — Professional Disposables International Professional Disposables International Hello, I own a Professional Disposables International that is covered by recall D-0572-2022 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.
