United StatesElevaris/Spectra Medical Devices Sodium Chloride Injection, 0.9% USP, 10 mL ampule (Model/Catalog AMPUL10MLK; product codes 1510-1/1510-2) in lots AB3005–AB3010, AB4001–AB4006, AB5001–AB5008 distributed to medical device kit packers in CA, FL, NC, OK, TX and VA is being recalled. The manufacturing firm Huons was cited for issues with product quality and sterility assurance; if sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter, which can cause inflammatory responses, infections, micro-clots, and organ failure.
What's being recalled
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.
Recalling firm: Spectra Medical Devices, Llc, Wilmington, MA, United States.
How to identify it
Lot Code: Product codes: 1510-1 (individual ampule) / 1510-2 (carton) Lots: AB3005, AB3006, AB3007, AB3008, AB3009, AB3010, AB4001, AB4002, AB4003, AB4004, AB4005 AB4006, AB5001, AB5002, AB5003, AB5004, AB5005,AB5006, AB5007, AB5008 No individual UDI, as this product is used only within convenience kits.
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)