Aligned Medical Solutions convenience kits containing Prevantics swabs or swabsticks are recalled due to uncertainty in drug manufacturing validation. Affected kits have specific AMS pack numbers and production dates.
Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International, that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products.
Aligned Medical Solutions convenience kits containing Prevantics swabs or swabsticks are being recalled because the drug products inside may not have been properly validated during manufacturing. This could affect the safety and effectiveness of the medical products.
The recall is based on uncertainty about whether the test methods used to manufacture the drug products were adequate. This could mean the products might not work as intended or could be unsafe for medical use.
Patients and healthcare providers who use these kits for medical procedures are likely affected. Those using the kits for critical procedures may be at higher risk due to potential product safety concerns.
Check the Aligned Medical Solutions convenience kits for specific AMS pack numbers listed in the recall notice. The kits include names like Ports Cath Pack, Minor Procedure Pack, and others with corresponding AMS numbers and production date ranges.
Identify the AMS pack number and production date range on your kit to confirm if it's affected by this recall.
The recall is due to uncertainty about the adequacy of the validation test methods used to manufacture the drug products, which could affect safety and effectiveness.
The official recall notice does not specify a remedy or action steps for affected products.
Kits with specific AMS pack numbers listed in the recall, such as Ports Cath Pack (1794)/AMS6569, Minor Procedure Pack (20527)/AMS6570B, and others with corresponding production date ranges.
We’ve drafted a message you can send Windstone Medical Packaging to request your refund or repair — edit it as you like.
Subject: Recall Z-1101-2022 — Windstone Medical Packaging Windstone Medical Packaging Hello, I own a Windstone Medical Packaging that is covered by recall Z-1101-2022 from Windstone Medical Packaging. 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.
