# FDA recall Z-2017-2018

> **Arrow International Inc** · Class II · device recall initiated 2018-04-11.

## Product

Percutaneous Sheath Introducer Kit with ARROWgard Blue¿ Sheath  and Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheters; Product Codes: MSO-29802-AHS and MSO-29903-AHS

## Reason for recall

Product sterility may be compromised due to unsealed packaging.

## Distribution

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

## Key facts

- **Recall number:** Z-2017-2018
- **Recalling firm:** Arrow International Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-11
- **Report date:** 2018-06-06
- **Termination date:** 2020-05-15

- **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-2017-2018

## Citation

> AI Analytics. FDA recall Z-2017-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2017-2018. Source: US FDA. Licensed CC0.

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