Recall Z-1731-2025— Galt Medical Corporation

Name: FDA recall Z-1731-2025
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. FDA's recall record names no specific 510(k) clearance for this event. Product: GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups.. 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

Product description

GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups.

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.