# FDA recall Z-0490-2019

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

## Product

Irrisept OR, Finished Bottle Assembly 450 ml STEP 1

## Reason for recall

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

## Distribution

AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, and WI

## Key facts

- **Recall number:** Z-0490-2019
- **Recalling firm:** Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-05
- **Report date:** 2018-11-28
- **Termination date:** 2024-09-23

- **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=Z-0490-2019

## Citation

> AI Analytics. FDA recall Z-0490-2019. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0490-2019. Source: US FDA. Licensed CC0.

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