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Recall Observatory FDA recall evidence

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

March 27, 2025

Class II

Product summary

Firm
Galt Medical Corporation
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

    reason.labeling_packaging · v1.0.0

    open seal