ICU Medical, Inc.

Otsuka ICU Medical Recalls One Lot of 0.9% Sodium Chloride Injection After Potassium Chloride Mix-Up

- Otsuka ICU Medical LLC issued a voluntary nationwide, user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 100 mL single pack after a product mix-up. - A customer complaint reported a 10 mEq highly concentrated potassium chloride bag inside an overwrap labeled as 0.9% sodium chloride injection. - The company states inadvertent injection of highly concentrated potassium chloride carries a reasonable probability of adverse events and potentially fatal outcomes. - No adverse events related to the recall have been reported to Otsuka ICU Medical LLC, and the FDA has been notified of the action.