Arrow International Inc: Medical Device Recall in 2018 - (Recall #: Z-1283-2018)

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:

Radial Artery Catheterization Kit; Model: AK-04020-C

Product Classification:

Class II

Date Initiated: October 26, 2017

Date Posted: April 11, 2018

Recall Number: Z-1283-2018

Event ID: 79314

Reason for Recall:

The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

Status: Terminated

Product Quantity: 24,192

Code Information:

Lots: 13F16H0430, 13F16M0224, 13F16M0242, 13F17F0150, 13F17F0475, 13F17G0240, 23F16E1193, 23F16F0476, 23F16G0085, 23F16H0013, 23F16H0680; Expiration dates: October 2018 through March 2020

Distribution Pattern:

US nationwide distribution, including Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated