# FDA recall D-0353-2025

> **B. Braun Medical Inc** · Class II · drug recall initiated 2025-03-31.

## Product

0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10

## Reason for recall

Presence of Particulate Matter

## Distribution

Product was distributed to 12 distributors who may have further distributed the product nationwide.

## Key facts

- **Recall number:** D-0353-2025
- **Recalling firm:** B. Braun Medical Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-03-31
- **Report date:** 2025-04-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0353-2025

## Citation

> AI Analytics. FDA recall D-0353-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0353-2025. Source: US FDA. Licensed CC0.

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