Device product
MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699; 2) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699A
Z-0515-2025
Product summary
- Event
- Event 95615
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2592 units
- Official record key
device-enforcement:Z-0515-2025
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) PAIN1699 UDI-DI: 10193489471908 (each) 40193489471909 (case), Lot Numbers: 22FLB063, 23BLB103, 23CLA768; 2) PAIN1699A UDI-DI: 10195327411107 (each) 40195327411108 (case), Lot Numbers: 23GLA369, 23ILA137
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.