# FDA recall D-0655-2022

> **B. Braun Medical, Inc.** · Class II · drug recall initiated 2022-02-25.

## Product

0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20

## Reason for recall

Lack of sterility assurance: leaking bags

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0655-2022
- **Recalling firm:** B. Braun Medical, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-02-25
- **Report date:** 2022-03-23
- **Termination date:** 2023-03-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allentown, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0655-2022

## Citation

> AI Analytics. FDA recall D-0655-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0655-2022. Source: US FDA. Licensed CC0.

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