Device product
Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal system REFERENCE PART NUMBER (RPN): DTN-18-20.0 ORDER NUMBER (GPN): G01377
Z-1526-2024
Product summary
- Event
- Event 94196
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 55 units
- Official record key
device-enforcement:Z-1526-2024
Official wording
Reason: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Code information: UDI: (01)00827002013773(17) Lot Number: 15786588
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