Device product
ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
Z-1690-2026
Product summary
- Event
- Event 98524
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 651,789
- Official record key
device-enforcement:Z-1690-2026
Official wording
Reason: Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.
Code information: UDI-DI 10888277314719 (ea) 40888277314710(case) All Lots
Distribution pattern: Worldwide - US Nationwide and the countries of Canada.
Derived failure modes
-
Unknown
Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.