LAKE FOREST, IL – ICU Medical, Inc. has announced a voluntary recall of one lot of Potassium Chloride Injection bags due to incorrect overwrap labeling, which could lead to potential dosing errors. The recall affects Potassium Chloride Injection 20 mEq bags that were mistakenly labeled as 10 mEq on the overwrap, while the primary IV bag inside correctly states 20 mEq.
Potential Risk to Patients
If a healthcare provider administers the medication based on the incorrect 10 mEq label, patients could receive double the intended potassium dose. This could lead to severe hyperkalemia, which may cause muscle weakness, paralysis, low blood pressure, cardiac arrhythmias, or even cardiac arrest. High-risk patients include premature infants, individuals with kidney disease, and those with a history of cardiac arrhythmias or on potassium-sparing diuretics.
No Reported Injuries
Although no adverse events have been reported so far, ICU Medical is urging healthcare providers to immediately stop using and distributing the affected product and return it to the place of purchase.
Affected Product Details
The recall involves lot number 1023172 with an expiration date of January 31, 2026. The mislabeled bags are packaged in cases labeled for Potassium Chloride Injection 20 mEq (NDC 0990-7075-26).
Customer Guidance
Healthcare facilities and providers who have purchased this product should contact ICU Medical for return instructions and product replacement options.
For further inquiries:
📞 Product Complaints: 1-844-654-7780 | Email: [email protected]
📞 Drug Safety Concerns: 1-844-654-7780 | Email: [email protected]
📞 Medical Inquiries: 1-800-241-4002 (Option 6) | Email: [email protected]
📞 Customer Care: 1-877-946-7747 (Option 1)
Adverse reactions or quality concerns can also be reported to the FDA MedWatch program online at www.fda.gov/medwatch/report.htm or via fax at 1-800-FDA-0178.
This recall is being conducted with the full knowledge of the U.S. Food and Drug Administration (FDA).
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