# FDA recall Z-0944-2023

> **Stradis Healthcare** · Class II · device recall initiated 2022-12-15.

## Product

Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.

## Reason for recall

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

## Distribution

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

## Key facts

- **Recall number:** Z-0944-2023
- **Recalling firm:** Stradis Healthcare
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-15
- **Report date:** 2023-01-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukegan, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0944-2023

## Citation

> AI Analytics. FDA recall Z-0944-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0944-2023. Source: US FDA. Licensed CC0.

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