Device 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.
Z-1731-2025
Product summary
- Event
- Event 96622
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,881 catheters
- Official record key
device-enforcement:Z-1731-2025
Official wording
Reason: Due to a potential open seal in the sterile barrier packaging .
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
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.
Derived failure modes
-
Labeling or packaging
open seal