Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue Recalled by Arrow International Inc Due to Some of the products listed in the recall...

Date: November 27, 2017
Company: Arrow International Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Arrow International Inc directly.

Affected Products

Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features 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.

Quantity: 23,904 in total

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 7 states: FL, KY, MI, NJ, OH, SC, TX

Affected (7 states)Not affected

About Arrow International Inc

Arrow International Inc has 431 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report