GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percuta...
FDA Recall #Z-1731-2025 — Class II — March 27, 2025
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 .
Recalling Firm
Galt Medical Corporation — Garland, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2,881 catheters
Distribution
Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.
Code Information
Catalog Number: DRC-002-05 UDI-DI codes: 00841268100381 Lot Number: 25051843 Catalog Number: DRC-002-06 UDI-DI code: 00841268100398 Lot Number: 25034783
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated