Early Alert: Convenience Kit Issue from Windstone Medical Packaging, Inc.

By Effective Medicine  On  In Drugs, Medical Devices 
Component Name Cardinal Health Part Number Aligned Medical Solutions Part Number Component Lot Number
Webcol Large Alcohol Prep Pad 5110 69124 25K006462

Full List of Affected Products

What to Do

Apply the Aligned Medical Solutions over-label (see Recall Notice image below) to affected inventory. When the affected convenience kits are opened for use, remove, discard and do not use the Cardinal Health Webcol Alcohol Prep Pads.

On May 21, 2026, Aligned Medical Solutions sent all affected customers a letter recommending the following actions:

  • Identify affected products.
  • Apply the provided over-labels according to the instructions provided.
  • When affected kits are opened for use, remove any Cardinal Health Alcohol Prep Pads.
  • Mark on the removed pads that they are to be disposed of and set them aside for disposal. 
  • Dispose of the recalled pads following medical waste policies at your institution.
  • Request replacement product as needed.
Recall Notice, Cardinal Health announced the recall of 5110 Webcol TM Large Alcohol Prep Pad contained in this kit after it was sealed and sterilized. All other components in the kit are not affected by this recall. At the time the kit is opened for use any Cardinal Alcohol Prep Pad should be identified and set aside. The recalled Cardinal Alcohol Prep Pad should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.

Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for Alert

Windstone Medical Packaging initiated an Urgent Medical Device Recall notice for convenience kits that contain Cardinal Health alcohol pads affected by a Cardinal Health Nationwide Recall. The Alcohol Prep Pads may be contaminated with Paenibacillus phoenicis. Use of contaminated pads for skin preparation before injections or blood draws poses risk of infection to vulnerable groups such as critically ill, immunocompromised, neonatal, and pediatric patients.

As of June 4, 2026, Windstone Medical Packaging has reported no serious injuries or deaths associated with this issue.

Device Use

The convenience kits contain various surgical instruments, dressings and/or other materials, and pharmaceutical components that are intended to be used during various surgical procedures.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Windstone Medical Packaging, Inc. at [email protected] or call (407) 638-9924.

Additional FDA Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?  

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Article source: http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-convenience-kit-issue-windstone-medical-packaging-inc

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