Recall Z-2588-2014— Galt Medical Corporation

Name: FDA recall Z-2588-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-25

Class II · Terminated

Class II FDA medical device recall by Galt Medical Corporation, initiated 2014-07-25, terminated 2016-02-26. It names one FDA 510(k) clearance: K112398. Product: GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.. Reason: The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient..

Recalling firm: Galt Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-07-25
Terminated: 2016-02-26
Firm location: Garland, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K112398 — TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORTGalt Medical·cleared 2012-04-12

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

GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.

Reason for recall

The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.

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