Device product
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
Z-1021-2025
Product summary
- Event
- Event 95874
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1090 units
- Official record key
device-enforcement:Z-1021-2025
Official wording
Reason: 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.
Code information: UDI-DI 04046964669286 (Primary); 04046964669279 (Unit of Use); Lot Number 0061916572
Distribution pattern: US Nationwide distribution in the states of MO, OK.
Derived failure modes
-
Unknown
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.