ICU Medical, Inc. of Illinois has issued an urgent recall of one lot of their Potassium Chloride Injection bags due to a labelling error. As reported by the FDA, use of the recalled product could result in patients receiving a dangerous overdose of potassium chloride.
Health care providers typically use Potassium Chloride Injection bags to administer potassium intravenously to patients who are unable replace their electrolytes orally. The outer labels on ICU Medical’s recalled bags of potassium chloride specify a dosage of 10 mEq, or 740 mg, while the actual dosage of potassium chloride included in the bags is 20 mEq, or 780 mg per 100 mL bag.
ICU Medical announced the recall on Thursday, February 13th, citing lot number 1023172 for the cases of Potassium Chloride Injection bags impacted. The National Drug Code (NDC) for the recalled lot is 0990-7075-26, while the NDCs for the mislabeled bags included in the lot are 0990-7074-26 and 0990-7075-26. The barcode number for the recalled lot is (01)30309907075267, and the barcode numbers for the recalled bags are (01)00309907074269 and (01)00309907075266. In addition to the mislabeled bags, the recalled cases also includes bags that are correctly marked with a dosage of 20 mEq on both the overwrap labels and the labels affixed to the bags. The recall includes all bags in lot 1023172.
At this time, ICU Medical has not received any reports of injury or death linked to the recalled lot of Potassium Chloride Injection bags. If a health care professional administers the recalled product thinking they are administering a 10 mEq dosage, the patient will receive an overdose of potassium chloride, as the bags contain a 20 mEq dose. Such an overdose could result in hyperkalemia, or an abnormally high blood level of potassium. This could be particularly dangerous for “premature infants, patients on chronic parenteral nutrition, patients who have a history of cardiac arrhythmias, patients with chronic renal insufficiency, patients who have acute renal failure, patients on potassium-sparing diuretics.” Is such instances, extremely elevated blood potassium levels can be fatal.
ICU Medical advises all health care professionals to avoid using the recalled product. The company has contacted all customers and distributors with instructions for returning the product for a replacement.
Anyone with questions or concerns about the recall can contact ICU Medical, Inc. at 1-877-946-7747 (option 1), Monday through Friday from 7 a.m. to 6 p.m. CST.
Patients and health care providers can report any new adverse health events related to ICU Medical’s recalled Potassium Chloride Injection bags through the FDA’s MedWatch Online Voluntary Reporting Form.
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