# FDA recall Z-3199-2018

> **Arrow International Inc** · Class II · device recall initiated 2018-07-17.

## Product

4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2

## Reason for recall

The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen catheter. This issue may cause a delay in treatment while a replacement catheter is obtained.

## Distribution

The products were distributed to the following US states:  AL, AZ, CA, GA, MA, MD, ME, MI, NY, PA, RI, SC, VA, and WA.

## Key facts

- **Recall number:** Z-3199-2018
- **Recalling firm:** Arrow International Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-17
- **Report date:** 2018-09-26
- **Termination date:** 2020-12-02

- **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-3199-2018

## Citation

> AI Analytics. FDA recall Z-3199-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-3199-2018. Source: US FDA. Licensed CC0.

---

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