Medical device recalls Moderate risk

Galt Medical Corporation recalls GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and…

Recall date
March 27, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1731-2025
FDA classification
Class II
Brand / firm
Galt Medical Corporation
Sold / distributed
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.

Why it was recalled

Due to a potential open seal in the sterile barrier packaging .

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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