# FDA recall Z-0997-2018

> **Arrow International Inc** · Class II · device recall initiated 2017-11-27.

## Product

Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R)    Product Usage:  The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to:  multiple infusions of fluids, medications, or chemotherapy  infusion of fluids that are hypertonic, hyperosmolar, or have  divergent pH values  frequent blood sampling or blood/blood component infusions  infusion of incompatible medications  central venous pressure monitoring  lack of usable peripheral IV sites  replacement of multiple peripheral sites for IV access  injection of contrast media  When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.    Catheter and Sharps Safety Features

## Reason for recall

Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.

## Distribution

US in the states of OH, FL, SC, TX, KY, NJ, MI

## Key facts

- **Recall number:** Z-0997-2018
- **Recalling firm:** Arrow International Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-27
- **Report date:** 2018-03-21
- **Termination date:** 2020-09-22

- **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-0997-2018

## Citation

> AI Analytics. FDA recall Z-0997-2018. Retrieved 2026-06-11 from https://api.ai-analytics.org/recall/Z-0997-2018. Source: US FDA. Licensed CC0.

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