Arrow International Inc: Medical Device Recall in 2018 - (Recall #: Z-0468-2019)

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:

Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use.

Product Classification:

Class II

Date Initiated: September 21, 2018

Date Posted: November 21, 2018

Recall Number: Z-0468-2019

Event ID: 81242

Reason for Recall:

The products labeling contains inconsistencies. In certain instances, the lidstock, banner card and shipper label state that the Spring Wire Guide (SWG) within is .032 rather than the correct SWG size .025 . For other lots in scope the lidstock correctly states the SWG size .025 however the banner card states the incorrect SWG size .032 .

Status: Terminated

Product Quantity: 3640

Code Information:

Lot/Batch Numbers: 13F17E0685 13F17F0562 13F17H0141 13F17K0340 13F18B0119 13R17E0685

Distribution Pattern:

US Nationwide distribution in the states of CA, FL, ID, IL, MI, NC, NJ, PA, and WI.

Voluntary or Mandated:

Voluntary: Firm initiated