# FDA recall Z-2329-2017

> **Arrow International Inc** · Class II · device recall initiated 2017-05-09.

## Product

1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter    2) Arrow PSI Kit

## Reason for recall

Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

## Distribution

Worldwide Distribution - US (nationwide) and Canada

## Key facts

- **Recall number:** Z-2329-2017
- **Recalling firm:** Arrow International Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-09
- **Report date:** 2017-06-21
- **Termination date:** 2018-09-17

- **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-2329-2017

## Citation

> AI Analytics. FDA recall Z-2329-2017. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2329-2017. Source: US FDA. Licensed CC0.

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