# FDA recall Z-3196-2018

> **Smiths Medical ASD Inc.** · Class III · device recall initiated 2018-07-13.

## Product

Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX.  The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.

## Reason for recall

The product was mislabeled with the incorrect label.

## Distribution

US Nationwide Distribution in the states of  CT, MA, MI, NC, NJ, NY, RI, TX, UT, and WA.

## Key facts

- **Recall number:** Z-3196-2018
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-13
- **Report date:** 2018-09-26
- **Termination date:** 2018-10-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3196-2018

## Citation

> AI Analytics. FDA recall Z-3196-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-3196-2018. Source: US FDA. Licensed CC0.

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