Recall Z-1733-2025— Galt Medical Corporation

Name: FDA recall Z-1733-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-27

Class II · Ongoing

Class II FDA medical device recall by Galt Medical Corporation, initiated 2025-03-27. It names one FDA 510(k) clearance: K043525. Product: B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.. Reason: Due to a potential open seal in the sterile barrier packaging ..

Recalling firm: Galt Medical Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-03-27
Firm location: Garland, TX, United States

510(k) clearances named in this recall

1 on FDA's record

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

B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.

Reason for recall

Due to a potential open seal in the sterile barrier packaging .

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