Class II
Terminated
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
- Recall Initiated
- May 23, 2023
- Posted
- June 7, 2023
- Recall Number
- D-0777-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 53,424 bags
- Firm Location
- Waltham, MA, United States
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.
Distribution
Product was distributed to 32 clinics in SC, NC and VA.
Lot / Code Info
Lot # 23AU05030, Exp 01/13/2024; 23AU05035, Exp 01/15/2024
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