ICU Medical issues recall of potassium chloride injection bags over labeling error

ICU Medical has issued a nationwide voluntary recall of one lot of its potassium chloride injection 20 mEq bags after discovering that some overwrap labels incorrectly state potassium chloride injection 10 mEq.

Announced on Feb. 13 and posted on the FDA website on Feb. 14, the labeling error stems from a manufacturing issue and could lead to incorrect dosing calculations, potentially resulting in severe hyperkalemia and life-threatening complications.

If a healthcare provider administers the mislabeled 20 mEq bag under the assumption that it contains 10 mEq, the patient could receive twice the intended dose of potassium chloride.

This could lead to cardiac arrhythmias, muscle weakness, paralysis, mental confusion, hypotension, or even cardiac arrest, particularly in vulnerable patient populations such as premature infants and those with kidney disease or heart conditions, according to ICU Medical. The company stated that, as of the recall date, it had not received any reports of adverse events linked to the issue.

The affected product, packaged in 100 mL flexible containers, is labeled with lot number 1023172 and an expiration date of Jan. 31, 2026. ICU Medical has notified customers and distributors of the recall, urging them to stop using and distributing the affected product and to return any mislabeled bags to the original place of purchase.

All healthcare professionals that have the recalled product should also stop use and further distribution, and return the mislabeled bags to the place of purchase. 

ICU Medical, based in San Clemente, California, develops medical technology focused on infection prevention and healthcare worker safety. Its products include IV therapy solutions, infusion pumps, needle-free access devices, hazardous drug handling systems, and hemodynamic monitoring tools.