Recall Z-1832-2024— Cook Medical Incorporated

Name: FDA recall Z-1832-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-01

Class II · Ongoing

Class II FDA medical device recall by Cook Medical Incorporated, initiated 2024-04-01. It names one FDA 510(k) clearance: K092359. Product: EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012. Reason: Devices may contain elevated levels of bacterial endotoxin..

Recalling firm: Cook Medical Incorporated
Classification: Class II
Status: Ongoing
Initiated: 2024-04-01
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K092359 — ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19ACook Ireland, Ltd.·cleared 2009-11-02

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

EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012

Reason for recall

Devices may contain elevated levels of bacterial endotoxin.

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