# FDA recall Z-2385-2018

> **Arrow International Inc** · Class II · device recall initiated 2018-05-17.

## Product

Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW    Product Usage:  To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).

## Reason for recall

Product pouch label may not easily identify the  lot number, expiration date and associated symbols..

## Distribution

US Nationwide Distribution in the states of AR, AZ, CT, FL, GA, IL, IN,  KS, KY, MA, MI, MN, MO, NC, NJ, NY, OH, PA, SC, TX, VA & WA

## Key facts

- **Recall number:** Z-2385-2018
- **Recalling firm:** Arrow International Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-17
- **Report date:** 2018-07-18
- **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-2385-2018

## Citation

> AI Analytics. FDA recall Z-2385-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2385-2018. Source: US FDA. Licensed CC0.

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