# FDA recall Z-1375-2019

> **Terumo Medical Corporation** · Class I · device recall initiated 2019-04-26.

## Product

SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925,   SR-1935,   SR-2025,   SR-2035,   SR-2225,   SR-2235,   SR-2425,   SR-2435

## Reason for recall

There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.

## Distribution

The products were distributed US nationwide.    The products were distributed to the following foreign countries:  Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, Singapore.

## Key facts

- **Recall number:** Z-1375-2019
- **Recalling firm:** Terumo Medical Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-26
- **Report date:** 2019-06-05
- **Termination date:** 2020-09-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Elkton, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1375-2019

## Citation

> AI Analytics. FDA recall Z-1375-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1375-2019. Source: US FDA. Licensed CC0.

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