# FDA recall Z-2818-2018

> **Arrow International Inc** · Class II · device recall initiated 2018-07-10.

## Product

HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702    The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous sheath introducer.

## Reason for recall

The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.

## Distribution

Worldwide Distribution: US (nationwide) to the following states of: AK, AL, CA, FL, HI, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NE, NY, OH, OR, PA, SC, SD, TX, WI, and WV; to countries of:: Finland, Germany, Hungary, Netherlands, South Africa, United Arab Emirates and the United Kingdom.

## Key facts

- **Recall number:** Z-2818-2018
- **Recalling firm:** Arrow International Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-10
- **Report date:** 2018-08-22
- **Termination date:** 2020-05-27

- **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-2818-2018

## Citation

> AI Analytics. FDA recall Z-2818-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2818-2018. Source: US FDA. Licensed CC0.

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