Z-2348-2024 Class II Ongoing
FDA device recall Z-2348-2024 was initiated by St. Jude Medical on April 30, 2024 and is designated Class II. Reason for recall: One lot of product has dilators that are too short and will not extend outside the introducer sheath. The recall status is ongoing. Affected quantity: 129 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2024
- Initiation Date
- April 30, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 129 units
Product Description
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Reason for Recall
One lot of product has dilators that are too short and will not extend outside the introducer sheath.
Distribution Pattern
US and Canada
Code Information
UDI/DI 05414734206099, Lot Number 10071090