# FDA recall Z-1101-2022

> **Windstone Medical Packaging, Inc.** · Class II · device recall initiated 2022-03-21.

## Product

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

## 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

US: PA, WA, FL, GA

## Key facts

- **Recall number:** Z-1101-2022
- **Recalling firm:** Windstone Medical Packaging, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-21
- **Report date:** 2022-05-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Billings, MT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1101-2022

## Citation

> AI Analytics. FDA recall Z-1101-2022. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1101-2022. Source: US FDA. Licensed CC0.

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