# FDA recall Z-0095-2022

> **Smiths Medical ASD Inc.** · Class II · device recall initiated 2020-03-10.

## Product

smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081

## Reason for recall

Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.

## Distribution

Austria, France, Germany, Great Britain, and Saudi Arabia

## Key facts

- **Recall number:** Z-0095-2022
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-10
- **Report date:** 2021-10-20
- **Termination date:** 2023-09-22

- **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-0095-2022

## Citation

> AI Analytics. FDA recall Z-0095-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0095-2022. Source: US FDA. Licensed CC0.

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