# FDA recall Z-0486-2018

> **Arrow International Inc** · Class II · device recall initiated 2017-07-10.

## Product

Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.

## Reason for recall

Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.

## Distribution

...

## Key facts

- **Recall number:** Z-0486-2018
- **Recalling firm:** Arrow International Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-10
- **Report date:** 2018-02-21
- **Termination date:** 2018-09-14

- **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-0486-2018

## Citation

> AI Analytics. FDA recall Z-0486-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0486-2018. Source: US FDA. Licensed CC0.

---

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