Arrow International Inc: Medical Device Recall in 2018 - (Recall #: Z-3199-2018)

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:

4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2

Product Classification:

Class II

Date Initiated: July 17, 2018

Date Posted: September 26, 2018

Recall Number: Z-3199-2018

Event ID: 80839

Reason for Recall:

The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen catheter. This issue may cause a delay in treatment while a replacement catheter is obtained.

Status: Terminated

Product Quantity: 1257 total

Code Information:

23F18B0428

Distribution Pattern:

The products were distributed to the following US states: AL, AZ, CA, GA, MA, MD, ME, MI, NY, PA, RI, SC, VA, and WA.

Voluntary or Mandated:

Voluntary: Firm initiated