Z-1526-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2024
- Initiation Date
- March 1, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 55 units
Product Description
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
Reason for Recall
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
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.
Code Information
UDI: (01)00827002013773(17) Lot Number: 15786588