Convenience Kit Correction: Windstone Medical Packaging, Inc. Issues Correction for Convenience Kit

The affected products and recommendations for what to do with the devices below have not changed. This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type.

This device may cause serious injury or death if you continue to use it without correction.Affected ProductThe FDA is aware that Windstone Medical Packaging, Inc., has issued a letter to affected customers recommending certain custom convenience kits be corrected prior to continued use by removing Cardinal Health Webcol large alcohol prep pads.Affected convenience kits:Device NameModel NumberUDI-DIDSAEK Pack - RXAMS12394BB098AMS12394B0Thyroid FNA Pack - RXAMS17729B098AMS177290Preop Kit - NSAMS18227B098AMS182270Dr. Lewin PackAMS7200DB098AMS7200D0Affected components contained within the convenience kits:Component NameCardinal Health Part NumberAligned Medical Solutions Part NumberComponent Lot NumberWebcol Large Alcohol Prep Pad51106912425K006462Full List of Affected ProductsWhat to DoApply 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. Reason for CorrectionWindstone 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 UseThe 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 InformationCustomers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Windstone Medical Packaging, Inc. at jjensen@alignedmedical.com or call (407) 638-9924.Additional FDA ResourcesFDA Enforcement ReportCDRH Medical Device Recall DatabaseCardinal Health Large Alcohol Pad Recall: FDA Enforcement ReportUnique 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 recognize a UDI on a label?AccessGUDID database - Identify Your Medical DeviceBenefits of a UDI SystemHow 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.Timeline of Communication UpdatesDateActions07/06/2026The FDA updated this communication to inform the public that this issue has been classified as a Class I Recall.06/16/2026The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue.