Spectra Medical recalls Sodium Chloride Flush ampules due to serious safety risk

Spectra Medical Devices has issued a recall of its Sodium Chloride Injection 0.9% USP 10 mL flush ampules that were manufactured by Huons Co., Ltd. The FDA classified the recall as the most serious type because the product could cause serious injury or death if used.

The recall covers individual ampules (catalog code AMPUL10MLK1510-1) and cartons (1510-2). Customers are instructed to examine their inventory immediately, discard or return any unused ampules, and notify downstream users.

Spectra Medical sent a letter to affected customers on July 6, urging extra vigilance for any patient health concerns and to forward the communication to all recipients of the product.

The company emphasizes that the affected devices must be removed from all points of use or sale to prevent potential harm.