Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions conve...
FDA Device Recall #Z-1101-2022 — Class II — March 21, 2022
Recall Summary
| Recall Number | Z-1101-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 21, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Windstone Medical Packaging, Inc. |
| Location | Billings, MT |
| Product Type | Devices |
| Quantity | 53,412 |
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.
Distribution Pattern
US: PA, WA, FL, GA
Lot / Code Information
AMS6569/ Between 142683 and 170329; AMS6570B/ Between 150682 and 170330; AMS6572A/Between 150863 and 170779; AMS6573/Between 153041 and 167712; AMS6828/Between 154460 and 165574; AMS6828A/167575, 168392; AMS9954/Between 152386 and 157483; AMS9954A/Between 157481 and 169200; AMS10234/Between 152202 and 159363; AMS10234A/Between 158104 and 169113; AMS10236/Between 152782 and 156962; AMS10236A/Between 157478 and 169198; AMS10238/Between 150032 and 160155; AMS10238A/Between 159664 and 166692; AMS10238B/Between 167164 and 168646; AMS10247/Between 146572 and 156705; AMS10247A/Between 157182 and 168754; AMS10249/Between 158599 and 161959; AMS10249A/Between 157256 and 169105; AMS10255/Between 150385, and 156000; AMS10255A/Between 157201 and 167493; AMS10256/153691; AMS10256A/Between 158498 and 163451; AMS10256B/Between 160447 and 169108; AMS10257/Between 158004 and 166979; AMS10271/150057; AMS10271A/Between 157910 and 168755; AMS10280/Between 150046 and 158682; AMS10280A/Between 157914 and 168539; AMS10710A/Between 154520 and 164202; AMS10897A/162161, 163158, 163524; AMS12381/Between 154627 and 156334; AMS12382/153165; AMS12735/164426; AMS-7192CS-8/155088, 156610, 156611; DDS1010G/153351, 157709, 157746; DDS1149/167640; VYMAXBASIC/Between 156613 and 165673
Other Recalls from Windstone Medical Packaging, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0031-2025 | Class II | Aligned Medical Tonsil Pack REF AMS14809 that c... | Aug 16, 2024 |
| Z-0030-2025 | Class II | Aligned Medical T and A Pack REF AMS11482 that ... | Aug 16, 2024 |
| Z-0027-2025 | Class II | Aligned Medical Tonsil Tray REF AMS9300A that c... | Aug 16, 2024 |
| Z-0028-2025 | Class II | Aligned Medical Tonsil ENT Pack REF AMS9977 tha... | Aug 16, 2024 |
| Z-0029-2025 | Class II | Aligned Medical Septo Pack REF AMS11480 that co... | Aug 16, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.