0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
Reported: March 1, 2023 Initiated: February 10, 2023 #D-0346-2023
Product Description
0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
Reason for Recall
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.
Details
- Recalling Firm
- B. Braun Medical Inc.
- Units Affected
- 1,343,982 bags
- Distribution
- USA Nationwide.
- Location
- Daytona Beach, FL
Frequently Asked Questions
What product was recalled? ▼
0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00. Recalled by B. Braun Medical Inc.. Units affected: 1,343,982 bags.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 1, 2023. Severity: Moderate. Recall number: D-0346-2023.
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