# FDA recall D-0112-2018

> **B. Braun Medical Inc** · Class II · drug recall initiated 2017-12-15.

## Product

0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10

## Reason for recall

Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap

## Distribution

Product was distributed nationwide.

## Key facts

- **Recall number:** D-0112-2018
- **Recalling firm:** B. Braun Medical Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-12-15
- **Report date:** 2017-12-27
- **Termination date:** 2018-10-18

- **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-0112-2018

## Citation

> AI Analytics. FDA recall D-0112-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0112-2018. Source: US FDA. Licensed CC0.

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