Windstone Medical Packaging, Inc. — Class II: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pac
Windstone Medical Packaging, Inc. has initiated a Class II recall for various Aligned Medical Solutions (AMS) medical convenience kits because they contain Elevaris Lidocaine HCl injection USP, which was recalled by Elevaris Medical Devices Inc. due to supplier quality issues. The recall encompasses 23 distinct part numbers, including various biopsy, arthrogram, and radiology trays.
This recall affects healthcare facilities and clinicians using AMS medical convenience kits, as well as regulatory and quality assurance professionals responsible for managing device recalls and supplier quality oversight.
The recall highlights the secondary regulatory impact on convenience kit manufacturers when a sub-component—in this case, a pharmaceutical injection—fails quality standards. It underscores the necessity for robust supplier management and the complexity of traceability within multi-component medical kits, where a failure in a third-party component necessitates a broad recall of the finished device assembly.
Quality and Supply Chain teams should immediately verify if any AMS medical convenience kits within their inventory are affected by this recall. Procurement departments should evaluate the status of sub-component suppliers, specifically regarding Elevaris Lidocaine HCl injections, and ensure that internal non-conformance procedures are initiated for any identified lots.
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) Loop Recorder Pack 2 -RX, Part Number AMS10164; 2) NY Tray - RX, Part Number AMS10276A; 3) NYC Tray - RX, Part Number AMS10281B; 4) Vein Pack - RX, Part Number AMS11398C; 5) Radiology Tray-RX, Part Number AMS1217A; 6) Custom Pack - RX, Part Number AMS12757B; 7) Biopsy Tray w/Lidocaine - RX, Part Number AMS13700; 8) Arthrogram Tray - RX, Part Number AMS13755A; 9) Myelogram Tray - RX, Part Number AMS14805A; 10) Arthrogram Tray - RX, Part Number AMS15071A; 11) Vein Pack - RX, Part Number AMS15270; 12) Myelogram Tray - RX, Part Number AMS15298; 13) Loop Pack - RX, Part Number AMS15643; 14) Basic Biopsy Tray - RX, Part Number AMS15662A; 15) Pain Pack -RX, Part Number AMS17021; 16) Pain Tray -RX, Part Number AMS17817; 17) Vasectomy Pack - RX, Part Number AMS18226; 18) Arthrogram Tray- RX, Part Number AMS2886(A; 19) Custom Pack - RX, Part Number AMS3081C; 20) Basic Procedure Pack - RX, Part Number AMS5497; 21) Basic Pack - RX, Part Number AMS8130C; 22) Supply Kit - RX, Part Number AMS9521A; 23) Maximal Sterile Barrier Vascular Access Procedure Kit - RX, Part Number VK0003MB.. Firm: Windstone Medical Packaging, Inc. (Billings MT United States). Status: Ongoing.
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