FDA-Device2025-05-14Class II
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.
Galt Medical Corporation
Hazard
Due to a potential open seal in the sterile barrier packaging .
Sold states
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.
Affected count
2,881 catheters
Manufactured in
2220 Merritt Dr, N/A, Garland, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1731-2025Don't want to check this manually?
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