Recall Z-2561-2018— Galt Medical Corporation

Name: FDA recall Z-2561-2018
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: K172487, K000737. Product: 1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Peripheral Access Kit, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; b) KIT-075-03. 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

K172487 — Coaxial Dilator Set (Micro-Introducer)Galt Medical Corp.·cleared 2017-10-16
K000737 — COAXIAL DILATOR SETXentek Medical, Inc.·cleared 2000-08-01

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

1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Peripheral Access Kit, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; b) KIT-075-03

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.