Device product
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
Z-1527-2024
Product summary
- Event
- Event 94196
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 296 units
- Official record key
device-enforcement:Z-1527-2024
Official wording
Reason: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Code information: UDI: (01)00827002094901(17) Lot Number: 15787864, 15804398
Distribution pattern: Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
Derived failure modes
-
Unknown
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility