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Early Alert: Convenience Kit Issue from Windstone Medical Packaging, Inc.
The 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. The firm initiated an Urgent Medical Device Recall notice due to Cardinal Health’s nationwide recall of the alcohol prep pads. These prep pads may be contaminated with Paenibacillus phoenicis, and use of the prep pads 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.
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Windstone Medical Packaging, Inc. at jjensen@alignedmedical.com or call (407) 638-9924.
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