Z-1021-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2025
- Initiation Date
- December 4, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1090 units
Product Description
Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for pain control. Model/Catalog Number: 530159
Reason for Recall
Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required catheter connector and therefore is unable to be used to administer medication.
Distribution Pattern
US Nationwide distribution in the states of MO, OK.
Code Information
UDI-DI 04046964669286 (Primary); 04046964669279 (Unit of Use); Lot Number 0061916572