Recall Z-2202-2016— Arrow International Inc

Name: FDA recall Z-2202-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-02

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2016-06-02, terminated 2017-08-21. It names one FDA 510(k) clearance: K810675. Product: Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.. Reason: Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2016-06-02
Terminated: 2017-08-21
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

Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.

Reason for recall

Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.

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