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FDAFDA · Food and drugs·Recall number Z-0994-2018

Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(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.

Published March 21, 2018 · Recall initiated: November 27, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Arrow International Inc
Distributor
US in the states of OH, FL, SC, TX, KY, NJ, MI
Lot
ASK-12703-PRJ 13F17B0279 13F17D0112 ASK-15703-PRJ 13F17B0265
Risk classification
Class II
Area (FDA)
device
Country
United States

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