Z-1531-2024 Class II Ongoing
FDA device recall Z-1531-2024 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: 1,493 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 24, 2024
- Initiation Date
- Mar 1, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,493 units
Product Description
Dilator With AQ Hydrophilic Coating - Intended to be 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 systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.0-38-20-HC G10207 2) JCD14.0-38-20-HC G10293 3) JCD16.0-38-20-HC G10206 4) JCD6.0-38-20-HC G10285 5) JCD8.0-38-20-HC G10289
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
Ref. Number/UDI-DI/Lot Numbers: 1) JCD10.0-38-20-HC (01)00827002102071(17) 15794369 2) JCD14.0-38-20-HC (01)00827002102934(17) 15778297, 15787264 3) JCD16.0-38-20-HC (01)00827002102064(17) 15794375 4)JCD6.0-38-20-HC (01)00827002102859(17) NS15808469 5) JCD8.0-38-20-HC (01)00827002102897(17) 15761259
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1531-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026