ModerateClass IIOngoing

FDA Devices recall · Reported May 25, 2022

Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers: Ports Cath Pack (1794)/AMS6569, Minor Procedure Pack (20527)/AMS6570B, Breast Biopsy Pack (24771)/AMS6572A, Bone Marrow Pack (11862)/AMS6573, Ultrasound Biopsy Pack -Rx/AMS6828, Ultrasound Biopsy Pack -Rx/AMS6828A, C Access Tray/AMS9954, C Access Tray/AMS9954A, Access Tray A/AMS10234, Access Tray A/AMS10234A, C-Access Tray Chicago/AMS10236, C-Access Tr

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on May 25, 2022. Severity: Moderate. Recall number: Z-1101-2022.

Q: Where was the recalled product distributed?

Distribution: US: PA, WA, FL, GA.

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-1101-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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 …

Recall #: Z-1101-2022
Affected scope: 53,412
Initiated: March 21, 2022

Compiled from official public sources by the editorial team.

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Windstone Medical Packaging, Inc. recalled Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutio… - a moderate-severity action.

Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutio… was recalled by Windstone Medical Packaging, Inc. in May 25, 2022. Reason: Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables I…. Check the official notice for the remedy. Verify recall #Z-1101-2022 with the FDA Devices before acting.

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The recall

Windstone Medical Packaging, Inc. issued this moderate-severity FDA Devices recall — Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables I….

Moderate
severity level: 53K units
affected scope: Class II
classification: May 25, 2022
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1101-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1101-2022) was formally reported on May 25, 2022, with the manufacturer initiating the action on March 21, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Windstone Medical Packaging, Inc. is listed as the recalling firm, operating out of Billings, MT. Federal records list the affected scope as 53,412.

The documented reason for this recall is: 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 te… Distribution data in the federal record shows the product reached: US: PA, WA, FL, GA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

53,412

Related Recalls

6 from same agency

Product description

Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers: Ports Cath Pack (1794)/AMS6569, Minor Procedure Pack (20527)/AMS6570B, Breast Biopsy Pack (24771)/AMS6572A, Bone Marrow Pack (11862)/AMS6573, Ultrasound Biopsy Pack -Rx/AMS6828, Ultrasound Biopsy Pack -Rx/AMS6828A, C Access Tray/AMS9954, C Access Tray/AMS9954A, Access Tray A/AMS10234, Access Tray A/AMS10234A, C-Access Tray Chicago/AMS10236, C-Access Tray Chicago/AMS10236A, Access Tray/AMS10238, Access Tray/AMS10238A, Access Tray/AMS10238B, Gray Pack/AMS10247, Gray Pack/AMS10247A, C-Access Tray/AMS10249, C-Access Tray/AMS10249A, C Access Tray/AMS10255, C Access Tray/AMS10255A, Jacksonville Tray/AMS10256, Jacksonville Tray/AMS10256A, Jacksonville Tray/AMS10256B, NVS Access Tray/AMS10257, AZ Access Tray/AMS10271, AZ Access Tray/AMS10271A, Fistulagram/ C-Access Pack/AMS10280, Fistulagram/ C-Access Pack/AMS10280A, Ultrasound Tray w/PDI/AMS10710A, Procedure Tray/AMS10897A, Universal Block Tray-RX/AMS12381, Ultrasound Injection-RX/AMS12382, Pellet Insertion Tray/AMS12735, PICC Insertion Tray - RX/AMS-7192CS-8, Breast Biopsy Tray/DDS1010G, Single Shot Epidural Tray-Rx/DDS1149, PICC Insertion Tray-RX/VYMAXBASIC

Reason for recall

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-1101-2022
Date reported	May 25, 2022
Date initiated	March 21, 2022
Recalling firm	Windstone Medical Packaging, Inc.
Firm location	Billings, MT
Affected scope	53,412
Distribution	US: PA, WA, FL, GA

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

53,412 units affected — limited or regional distribution scale.

Regional (<10K units) —

Multi-state (10K – 100K units) ✓ This recall

Large-scale (100K – 1M units) —

Massive (≥1M units) —

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1101-2022) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting — recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on May 25, 2022. Severity: Moderate. Recall number: Z-1101-2022.

Where was the recalled product distributed? ▼

Distribution: US: PA, WA, FL, GA.

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-1101-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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What to do next

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Data Sources

Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported May 25, 2022.

Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.