Arrow International Inc: Medical Device Recall in 2019 - (Recall #: Z-0053-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access

Product Classification:

Class II

Date Initiated: May 17, 2019

Date Posted: October 16, 2019

Recall Number: Z-0053-2020

Event ID: 82984

Reason for Recall:

Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner.

Status: Terminated

Product Quantity: 3,143

Code Information:

Lot/Batch Numbers: 13F18C0374, 13F18H0580, 13F18D0504, 13F18L0507, 13F18E0380, 13F18L0714, 13F18G0180, 13F18L0936, 13F18G0480

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated