Device product
MEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT, REF PAIN1876A
Z-0514-2025
Product summary
- Event
- Event 95615
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 360 units
- Official record key
device-enforcement:Z-0514-2025
Official wording
Reason: The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Code information: Codes: 1) PAIN1876A UDI-DI: 10195327433666 (each) 40195327433667 (case), Lot Number: 23KLA330
Distribution pattern: US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands
Derived failure modes
-
Unknown
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.