# FDA recall Z-2071-2021

> **Arrow International Inc** · Class II · device recall initiated 2021-05-19.

## Product

Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer  Product Code:  AI-07155-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

## Reason for recall

Marketed without a 510K

## Distribution

US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.

## Key facts

- **Recall number:** Z-2071-2021
- **Recalling firm:** Arrow International Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-05-19
- **Report date:** 2021-07-21

- **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-2071-2021

## Citation

> AI Analytics. FDA recall Z-2071-2021. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-2071-2021. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*