Recall Z-2562-2018— Galt Medical Corporation

Name: FDA recall Z-2562-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-02

Class II · Terminated

Class II FDA medical device recall by Galt Medical Corporation, initiated 2018-05-02, terminated 2020-07-20. It names 2 FDA 510(k) clearances: K173287, K043525. Product: Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055. Reason: The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient..

Recalling firm: Galt Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-05-02
Terminated: 2020-07-20
Firm location: Garland, TX, United States

510(k) clearances named in this recall

2 on FDA's record

K173287 — Elite HV RadialGalt Medical Corp.·cleared 2017-12-21
K043525 — CATHETER INTRODUCERGalt Medical Corp.·cleared 2005-02-09

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

Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055

Reason for recall

The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.

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