Arrow International Inc: Medical Device Recall in 2018 - (Recall #: Z-0997-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 27, 2017

Date Posted: March 21, 2018

Recall Number: Z-0997-2018

Event ID: 79339

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.

Status: Terminated

Product Quantity: 23,904 in total

Code Information:

ASK-45703-PRJ 13F16M0019 13F17B0343 13F17D0113 13F17G0059 13F17H0095

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated