Multi event Drug Recall Enforcement Report Class II voluntary initiated by B. Braun Medical Inc., originally initiated on 02-10-2023 for the product 0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00 The product was recalled due to lack of sterility assurance: recall of certain batches of 0.9% sodium chloride for injection usp in excel¿ plus iv container product due to the possibility of an incomplete seal that may cause leakage. the impacted lots may exhibit microscopic channel leaks near the port assembly of the product.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
D-0346-2023 | 02-10-2023 | 03-01-2023 | Class II | 1,343,982 bags | 0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00 | Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product. | Ongoing |
D-0347-2023 | 02-10-2023 | 03-01-2023 | Class II | 483,229 bags | 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10 | Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product. | Ongoing |
Recalled Products
NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
0264-5802 | Sodium Chloride | Sodium Chloride | Injection, Solution | Intravenous | B. Braun Medical Inc. | Human Prescription Drug |
0264-5804 | Sodium Chloride | Sodium Chloride | Injection, Solution | Intravenous | B. Braun Medical Inc. | Human Prescription Drug |