# FDA recall Z-0152-2022

> **Smiths Medical ASD Inc.** · Class II · device recall initiated 2020-12-08.

## Product

smiths medical portex Loss of Resistance Device, REF 100/398/000

## Reason for recall

The labeling was missing information on sterilization and prohibition of reuse.

## Distribution

Canada. Belgium, Great Britain, Ireland, Czech Republic, Spain, France, Switzerland, Israel, Germany, Sweden, Italy, New Zealand, Australia, South Africa, Netherlands, Slovenia, United Arab Emirates

## Key facts

- **Recall number:** Z-0152-2022
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-08
- **Report date:** 2021-10-27
- **Termination date:** 2023-08-04

- **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-0152-2022

## Citation

> AI Analytics. FDA recall Z-0152-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0152-2022. Source: US FDA. Licensed CC0.

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