Windstone Medical Packaging, Inc.: Port Introducer Kit
Convenience Kit Correction Summary Windstone Medical Packaging, Inc. is correcting Convenience Kits that contain certain Cardinal Health Webcol Large Alcohol Prep Pads manufactured by Aligned Medical Solutions because these pads are not sterile as intended. The affected kits were manufactured and distributed by Windstone Medical Packaging, Inc. The issue applies to custom convenience kits that included these specific alcohol prep pads.
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19
- Reason
- Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-17
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/44f855b6-a6f9-4301-ad62-7509bc800126