The recall affects lot 1042188 of 100 mL Sodium Chloride bags, distributed across the United States between December 30, 2025, and June 22, 2026. While the outer overwrap is labeled as standard saline, the internal bag may contain 10 mEq Potassium Chloride, a concentrated additive that can trigger fatal neuromuscular dysfunction, cardiac dysrhythmias, and hypotension if administered inadvertently. The error surfaced following a direct customer complaint.
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Otsuka ICU Medical Recalls Saline Bags Over Fatal Mix-Up Risk
A potential packaging error has prompted a nationwide recall of 0.9% Sodium Chloride Injection, as some units may contain highly concentrated Potassium Chloride instead. The mix-up poses a severe risk of cardiac arrest and death for vulnerable patients, though no adverse events have been reported to date.
Otsuka ICU Medical LLC is contacting distributors and healthcare facilities to quarantine and return the identified stock immediately. While the internal bag is clearly labeled as potassium chloride, the company warns that the discrepancy between the overwrap and the product inside presents a critical safety hazard. Facilities holding this lot are urged to stop all use and contact the manufacturer to coordinate returns. Patients at highest risk include premature infants, those with renal failure, and individuals with a history of cardiac arrhythmias.
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