# FDA recall D-0549-2018

> **B. Braun Medical Inc** · Class II · drug recall initiated 2018-02-16.

## Product

0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA  92614, Catalog # R5200-01, NDC 0264-2201-00.

## Reason for recall

Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0549-2018
- **Recalling firm:** B. Braun Medical Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-02-16
- **Report date:** 2018-03-07
- **Termination date:** 2020-01-23

- **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-0549-2018

## Citation

> AI Analytics. FDA recall D-0549-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0549-2018. Source: US FDA. Licensed CC0.

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