Class II
Ongoing
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
This recall is currently active, issued December 14, 2022. It was issued by Fresenius Medical Care Holdings, Inc..
- Recall Initiated
- November 22, 2022
- Posted
- December 14, 2022
- Recall Number
- D-0075-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4,097 cases/12 bags per case
- Firm Location
- Waltham, MA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Distribution
Product was distributed Nationwide in the USA.
Lot / Code Info
Lot # 22HU05062, 22HU06059, 22HU05035, EXP 06/30/2023; 22JU05001, EXP 07/31/2023
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