Some of the 20 mEq injection bags were incorrectly labeled as 10 mEq on the overwrap, which could lead to severe dosing errors. If a healthcare provider calculates a dose based on the incorrect label, this could lead to an overdose and could increase the risk of hyperkalemia, cardiac arrhythmias, paralysis or even death, according to a Feb. 14 news release from the FDA.
The recall affects lot 1023172 with an expiration date of Jan. 31, 2026. Healthcare providers are advised to stop using the affected products and return them. ICU Medical has not received reports of adverse events, the release said.
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