# FDA recall D-0159-2018

> **Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company** · Class II · drug recall initiated 2017-09-05.

## Product

Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005585

## Reason for recall

Lack of sterility assurance:  leaking containers which could lead to exposure to infectious agents.

## Distribution

IA, WI

## Key facts

- **Recall number:** D-0159-2018
- **Recalling firm:** Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-09-05
- **Report date:** 2018-01-17
- **Termination date:** 2018-12-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Vernon Hills, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0159-2018

## Citation

> AI Analytics. FDA recall D-0159-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0159-2018. Source: US FDA. Licensed CC0.

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