# FDA recall Z-1969-2023

> **Galt Medical Corporation** · Class II · device recall initiated 2023-05-08.

## Product

Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)

## Reason for recall

Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use of a replacement device.

## Distribution

Worldwide - US Nationwide distribution in the states of PA, UT, FL, PA, OH, GA, MA, NV, CA, NY, NJ and the countries of UK, AU, TR, FR, CH, NO.

## Key facts

- **Recall number:** Z-1969-2023
- **Recalling firm:** Galt Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-08
- **Report date:** 2023-06-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Garland, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1969-2023

## Citation

> AI Analytics. FDA recall Z-1969-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1969-2023. Source: US FDA. Licensed CC0.

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