The U.S. Food and Drug Administration has issued a correction notice for Cardinal Health Webcol Large Alcohol Prep Pads distributed through custom convenience kits manufactured by Aligned Medical Solutions and Windstone Medical Packaging, Inc. Certain batches of these commonly used medical devices failed to meet mandatory FDA sterility requirements, despite being labeled as sterile products intended for skin preparation before injections and blood draws.
The sterility discrepancy poses a significant infection control risk in healthcare settings where aseptic technique is critical. Non-sterile alcohol prep pads can introduce pathogenic microorganisms during procedures that require strict infection prevention protocols. Healthcare facilities currently using affected batches are advised to immediately quarantine inventory and review distribution and usage records to identify which clinical units may have received compromised products.
Institutions should contact their suppliers for replacement stock with verified sterility certification. This correction underscores the importance of maintaining rigorous device verification protocols in healthcare supply chains.
Read the full article on GMJ Newsroom.
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