FDA Enforcement
Class II
Ongoing
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
Recall: Z-1526-2024
·
Reported April 24, 2024
Enforcement
- Recall Number
- Z-1526-2024
- Event ID
- 94196
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cook Incorporated
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 24, 2024
- Initiation Date
- March 1, 2024
- Classification Date
- April 12, 2024
- Address
- 750 N Daniels Way, Bloomington, IN, 47404-9120, United States
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
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Code Info
UDI: (01)00827002013773(17) Lot Number: 15786588
Distribution
Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
Quantity
55 units