Otsuka ICU Medical LLC is recalling 509,360 units of 0.9% Sodium Chloride Injection, USP (100 mL bags). The recall was initiated because of a potential for the flexible containers to leak, which compromises the sterility of the saline solution. Using a non-sterile injectable product can lead to serious systemic infections.
A leak in the flexible container allows for the entry of microorganisms, compromising the sterility of the injection. If a non-sterile saline solution is administered to a patient, it can cause bloodstream infections or other severe health complications.
Distributed by ICU Medical, Inc., Lake Forest, Illinois
Incorrect Overwrap label showing 10 mEq Potassium chloride injection
Correct Overwrap label showing 20 mEq Potassium chloride injection
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If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · FDA Press Release · Raw API Response
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