AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E ; 2) Single Shot Epidural Tray - RX, Part Number AMS11296A; 3) Nerve Block Tray - RX, Part Number AMS11314A; 4) Epidural Tray - RX, Part Number AMS11910A; 5) Nerve Bloc
Windstone Medical Packaging, Inc.
The hazard
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. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E ; 2) Single Shot Epidural Tray - RX, Part Number AMS11296A; 3) Nerve Block Tray - RX, Part Number AMS11314A; 4) Epidural Tray - RX, Part Number AMS11910A; 5) Nerve Block Tray - RX, Part Number AMS12171; 6) Single Shot Epidural Tray - RX, Part Number AMS12219A; 7) Universal Block Tray - RX, Part Number AMS12381B.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model Part Number AMS1095(EModel UDI/DI B098AMS1095(E0Model Lot Numbers: 231043Model Part Number AMS11296AModel UDI/DI B098AMS11296A0Model Lot Numbers: 229846Model Part Number AMS11314AModel UDI/DI B098AMS11314A0Model Lot Numbers: 216803Model 240843Model Part Number AMS11910AModel UDI/DI B098AMS11910A0Model Lot Numbers: 230645Model 231078Model Part Number AMS12171Model UDI/DI B098AMS121710Model Lot Numbers: 230958Model 231238Model 241232Model Part Number AMS12219AModel UDI/DI B098AMS12219A0Model Lot Numbers: 217313Model Part Number AMS12381BModel UDI/DI B098AMS12381B0Model Lot Numbers: 230948.Would you have heard about this one?
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