Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.
Spectra Medical Devices, Llc
The hazard
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure. FDA Class I recall.
The remedy
Follow FDA guidance
About this recall
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model AB3006Model AB3007Model AB3008Model AB3009Model AB3010Model AB4001Model AB4002Model AB4003Model AB4004Model AB4005 AB4006Model AB5001Model AB5002Model AB5003Model AB5004Model AB5005Model AB5006Model AB5007Model AB5008 No individual UDIModel as this product is used only within convenience kits.Would you have heard about this one?
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