SODIUM CHLORIDE Recall D-0062-2023
Description: 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
SODIUM CHLORIDE Recall D-0062-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0062-2023 |
| Event ID | 91113 |
| Brand | SODIUM CHLORIDE |
| Generic Name | SODIUM CHLORIDE |
| Manufacturer | SODIUM CHLORIDE |
| Original Package? | 1 |
| Active Substance | SODIUM CHLORIDE |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide in the USA |
| Quantity | 137,120 bags |
| Recall Reason | Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility. |
| Drug Classification | Class II |
| Drug Code Info | 20221123 |
| Product NDC | 0990-7730 0990-7983 0990-7984 |
| Recall Initiation Date | 20221109 |
| Report Date | 20221123 |
| Classification Date | 20221116 |
| Address | 600 N Field Dr Lake Forest, IL 60045-4835 United States |
| Recalling Firm | ICU Medical Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 451W47IQ8X |
| Drug Application Number | NDA018090 |
| Structured Product Labeling (SPL ID) | 8f4215d3-c520-42e6-a155-a72bcf5ab63c |
| Structured Product Labeling (SPL Set ID) | 5f372b75-d7a4-471e-8ac6-290040fc84b0 |
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