# FDA recall Z-1281-2018

> **Arrow International Inc** · Class II · device recall initiated 2017-10-26.

## Product

Radial Artery Catheterization Kit; Model: AK-04018

## Reason for recall

The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

## Distribution

US nationwide distribution, including Puerto Rico.

## Key facts

- **Recall number:** Z-1281-2018
- **Recalling firm:** Arrow International Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-26
- **Report date:** 2018-04-11
- **Termination date:** 2019-12-10

- **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-1281-2018

## Citation

> AI Analytics. FDA recall Z-1281-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1281-2018. Source: US FDA. Licensed CC0.

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