# FDA recall Z-2576-2018

> **Arrow International Inc** · Class II · device recall initiated 2018-05-23.

## Product

Percutaneous Sheath Introducer Kit for use with 7 -  7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807.  The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.

## Reason for recall

Product contains dry natural rubber latex.  Label states Latex Free.

## Distribution

Puerto Rico

## Key facts

- **Recall number:** Z-2576-2018
- **Recalling firm:** Arrow International Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-23
- **Report date:** 2018-08-08
- **Termination date:** 2020-05-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Reading, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2576-2018

## Citation

> AI Analytics. FDA recall Z-2576-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2576-2018. Source: US FDA. Licensed CC0.

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