Recall Z-0468-2014— Arrow International Inc

Name: FDA recall Z-0468-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-09

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2013-10-09, terminated 2015-08-12. It names 2 FDA 510(k) clearances: K112554, K780532. Product: Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.. Reason: There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patient..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2013-10-09
Terminated: 2015-08-12
Firm location: Reading, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K112554 — TRANSRADIAL ARTERY ACCESS DEVICESTeleflexmedical, Inc.·cleared 2011-11-18
K780532 — PERCUTANEOUS SHEATH INTRODUCER KITArrow Intl., Inc.·cleared 1978-04-21

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

Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.

Reason for recall

There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patient.

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