# FDA recall Z-0714-2019

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

## Product

Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿   ¿¿¿     ¿¿¿

## Reason for recall

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

## Distribution

Worldwide distribution: US (nationwide) to states of: 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, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.

## Key facts

- **Recall number:** Z-0714-2019
- **Recalling firm:** Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-05
- **Report date:** 2019-02-13
- **Termination date:** 2024-04-16

- **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-0714-2019

## Citation

> AI Analytics. FDA recall Z-0714-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0714-2019. Source: US FDA. Licensed CC0.

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