Arrow International Inc: Medical Device Recall in 2018 - (Recall #: Z-2886-2018)

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:

Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multiple-lumen catheter permits venous access to the central circulation of pediatric patients. The ARROWg+ard antimicrobial surface is intended to help provide protection against catheterrelated infections. The catheter is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use. The use of the 4, 5, and 5.5 Fr. antimicrobial surface catheters in infants weighing less than 2.0, 2.5, and 3.0 kilograms respectively, have not been evaluated. Therefore, the benefits of these catheters in infants weighing less than the indicated weights should be weighed against any possible risks.

Product Classification:

Class II

Date Initiated: July 3, 2018

Date Posted: August 29, 2018

Recall Number: Z-2886-2018

Event ID: 80631

Reason for Recall:

One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter. However, this product is incorrectly labeled as AK-25502, so the lidstock says it contains a 2-lumen, 5 Fr x 8 cm catheter. No patient injuries have been reported related to this issue.

Status: Terminated

Product Quantity: 166

Code Information:

13F17K0202

Distribution Pattern:

Distributors in MO and UT. Medical facilities in AL, CA, IL, MA, NH, NM, NY, TX, VA, and WI.

Voluntary or Mandated:

Voluntary: Firm initiated