Recall Z-1284-2018— Arrow International Inc

Name: FDA recall Z-1284-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-26

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2017-10-26, terminated 2019-12-10. It names one FDA 510(k) clearance: K810675. Product: Radial Artery Catheterization Kit; Model: AK-04120. Reason: 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..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2017-10-26
Terminated: 2019-12-10
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K810675 — ARROW RADIAL ARTERY CATHETERIZATION SETArrow Intl., Inc.·cleared 1981-03-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Radial Artery Catheterization Kit; Model: AK-04120

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.