FDA-Device2024-04-24Class II
Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. REFERENCE PART NUMBER (RPN): DTVN-5.0-19-10.0- YUEH ORDER NUMBER (GPN): G09490
Cook Incorporated
Hazard
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Sold states
Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
Affected count
296 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. REFERENCE PART NUMBER (RPN): DTVN-5.0-19-10.0- YUEH ORDER NUMBER (GPN): G09490
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1527-2024Don't want to check this manually?
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