Recall Z-1362-2016— Us Endovascular

Name: FDA recall Z-1362-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-11

Class II · Terminated

Class II FDA medical device recall by Us Endovascular, initiated 2016-02-11, terminated 2017-11-30. It names one FDA 510(k) clearance: K152230. Product: USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO.. Reason: Product may kink during use rendering the product unusable..

Recalling firm: Us Endovascular
Classification: Class II
Status: Terminated
Initiated: 2016-02-11
Terminated: 2017-11-30
Firm location: Saint Louis, MO, United States

510(k) clearances named in this recall

1 on FDA's record

K152230 — Ebony PTA .014 RX Pheripheral Dilatation CatheterNatec Medical·cleared 2015-09-03

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

USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO.

Reason for recall

Product may kink during use rendering the product unusable.

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