Professional Disposables International recalls Prevantics Maxi Swabsticks due to manufacturing quality issues. The products may have inconsistent test validation affecting safety. Consumers should check product details and contact the company for guidance.
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Professional Disposables International is recalling Prevantics Maxi Swabsticks because of manufacturing quality concerns. This recall is due to potential inconsistencies in test validation that could affect product safety.
The recall is based on cGMP deviations related to the uncertainty of test method validation during manufacturing. This could lead to inconsistent product quality, but the specific risk to users is not described as causing serious injury or death in normal use.
Users of Prevantics Maxi Swabsticks, particularly those who use the product for medical or professional purposes. Individuals with specific medical conditions or those using the swabs for critical applications may be at higher risk.
Check for the product name 'Prevantics Maxi Swabstick' with NDC numbers 10819-4076-4 or 10819-4076-3. The lot numbers listed in the recall include specific expiration dates and packaging details.
Identify the NDC numbers (10819-4076-4 or 10819-4076-3) and lot numbers provided in the recall notice.
The recall is due to cGMP deviations in manufacturing, specifically uncertainty about the adequacy of test method validation, which could affect product safety.
Look for the NDC numbers 10819-4076-4 or 10819-4076-3 on the packaging, and check the lot numbers listed in the recall notice.
The recall does not specify a remedy, so contact Professional Disposables International 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-0570-2022 — Professional Disposables International Professional Disposables International Hello, I own a Professional Disposables International that is covered by recall D-0570-2022 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.
