Prevantics Swabs in Aligned Medical Solutions Kits: Drug Recall Due to Manufacturing
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.
Recall notice
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/60917-prevantics-swabs-in-aligned-medical-solutions-kits-drug-recall-due.
Source Summary by GovInfoNow · govinfonow.com/recall/60917-prevantics-swabs-in-aligned-medical-solutions-kits-drug-recall-due · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1101-2022
Cite this page
“Prevantics Swabs in Aligned Medical Solutions Kits: Drug Recall Due to Manufacturing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60917-prevantics-swabs-in-aligned-medical-solutions-kits-drug-recall-due. Based on FDA recall #Z-1101-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1101-2022%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Windstone Medical Packaging- Category
Medical device
What to do — step by step
Check Kit Details
Identify the AMS pack number and production date range on your kit to confirm if it's affected by this recall.
Where it went and when
Where it was distributed
Distributed in 4 states.
FDA distribution: “US: PA, WA, FL, GA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Georgia, Pennsylvania, Washington.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1101-2022 (March 21, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1101-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.