Device product
MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter Connector
Z-0508-2025
Product summary
- Event
- Event 95615
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1975 units
- Official record key
device-enforcement:Z-0508-2025
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: UDI/DI 10193489490312 (each), 40193489490313 (case), Lot Numbers: 21ABD173, 21EBC720, 21GBG632, 21HBF316, 21IBH392, 21IBM516, 21JBJ902, 21JBP187, 22IBL115, 22KBD213, 22OBI434, 23ABA553, 23ABO991, 23BBG757, 23CBO551, 23EBT535
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.