Product: Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10
Reason for recall: Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
Recall initiated: 20230523
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated