Z-1526-2024 Class II Ongoing
FDA device recall Z-1526-2024 was initiated by Cook Incorporated on Mar 1, 2024 and is designated Class II. Reason for recall: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility The recall status is ongoing. Affected quantity: 55 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 24, 2024
- Initiation Date
- Mar 1, 2024
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1526-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026