# FDA recall D-0346-2023

> **B. Braun Medical Inc.** · Class II · drug recall initiated 2023-02-10.

## 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

## 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.

## Distribution

USA Nationwide.

## Key facts

- **Recall number:** D-0346-2023
- **Recalling firm:** B. Braun Medical Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2023-02-10
- **Report date:** 2023-03-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Daytona Beach, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0346-2023

## Citation

> AI Analytics. FDA recall D-0346-2023. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0346-2023. Source: US FDA. Licensed CC0.

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