Windstone Medical Packaging, Inc. — Class II: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray
Windstone Medical Packaging, Inc. initiated a Class II recall for specific Aligned Medical Solutions (AMS) medical convenience kits, including Nerve Block and Universal Block Trays. The action was prompted by a supplier quality issue involving Elevaris Lidocaine HCl injection USP contained within the kits.
Regulatory, Quality, and Supply Chain professionals at medical device kit packagers and healthcare facilities utilizing AMS Nerve Block or Universal Block Trays.
This recall highlights the downstream regulatory risks for medical convenience kit manufacturers when a third-party drug component fails quality standards. It suggests that kit assemblers must maintain robust traceability systems to respond to supplier-initiated recalls and ensures that cross-industry (drug-to-device) quality failures are addressed in post-market surveillance.
Verify if any stocked Nerve Block or Universal Block Trays (AMS13975A, AMS2009, AMS3224) are subject to this recall. QA teams should evaluate current supplier qualification protocols for kit components to ensure upstream drug recalls are effectively tracked through the final kit assembly level.
Class II. 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.. Product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, Part Number AMS13975A; 2) Universal Block Tray- RX, Part Number AMS2009; 3) Nerve Block Tray - RX, Part Number AMS3224.. Firm: Windstone Medical Packaging, Inc. (Billings MT United States). Status: Ongoing.
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