# FDA recall Z-1993-2021

> **Smiths Medical ASD Inc.** · Class II · device recall initiated 2021-05-14.

## Product

PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel.

## Reason for recall

One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit.

## Distribution

US Nationwide distribution in the states of PA, MI, MD, FL.

## Key facts

- **Recall number:** Z-1993-2021
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-14
- **Report date:** 2021-07-07
- **Termination date:** 2023-06-09

- **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-1993-2021

## Citation

> AI Analytics. FDA recall Z-1993-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1993-2021. Source: US FDA. Licensed CC0.

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