Z-1330-2025 Class II Ongoing
FDA device recall Z-1330-2025 was initiated by Cordis US Corp on February 7, 2025 and is designated Class II. Reason for recall: Catheter manufactured at the incorrect length. The recall status is ongoing. Affected quantity: 12 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 19, 2025
- Initiation Date
- February 7, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
Product Description
Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Reason for Recall
Catheter manufactured at the incorrect length.
Distribution Pattern
US: WA OUS: Japan
Code Information
UDI: 20705032042991/ Lot Number: 18368326