Windstone Medical issues correction for non-sterile alcohol prep pads in custom convenience kits
Windstone Medical Packaging, Inc. has released a correction notice for several custom convenience kits that include Cardinal Health Webcol large alcohol prep pads that were found to be non-sterile.
The FDA has classified this recall as the most serious type, indicating that continued use of the uncorrected pads could cause serious injury or death. The correction does not require removal of the kits from inventory or from use; instead, users must apply an over-label and discard the affected pads before proceeding.
The kits affected include the SA EK Pack, Thyroid FNA Pack, Preop Kit, and Dr. Lewin Pack, each identified by specific model numbers and UDI codes. The non-sterile component is the Cardinal Health Webcol large alcohol prep pad with part number 51106912425 and lot number K006462.
Aligned Medical Solutions, the manufacturer of the kits, sent a letter on May 21, 2026 advising customers to identify the affected products, apply the provided over-labels, and remove and discard the pads when the kits are opened.
This writeup was produced by pharmadog from original reporting by fda medwatch.
Original headline: “Convenience Kit Correction: Windstone Medical Packaging, Inc. Issues Correction for Convenience Kit”
read at fda medwatch ↗
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