Z-1731-2025 Class II Ongoing

Recalled by Galt Medical Corporation — Garland, TX

Recall Details

Product Type
Devices
Report Date
May 14, 2025
Initiation Date
March 27, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,881 catheters

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 .

Distribution Pattern

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