The FDA has classified Spectra Medical Devices’ recall of certain 10 mL Sodium Chloride Injection 0.9% USP flush ampules as its most serious type because continued use could cause serious injury or death.

The ampules, manufactured by Huons Co., are being removed following an FDA inspection that identified manufacturing quality issues. Potential sterility failures could expose patients to microorganisms, endotoxins, or foreign matter, potentially causing infection, systemic inflammatory responses, micro-clots or organ failure, particularly among high-risk patients.

Healthcare providers should immediately identify affected lots and discard or return unused ampules. Distributors should notify customers and ensure affected products are removed from inventory and use. As of July 6, Spectra had reported no serious injuries or deaths associated with the recall.

The products are used to flush IV tubing and indwelling vascular-access devices. Affected catalog codes include AMPUL10MLK, 1510-1 and 1510-2.