FDA-Device2026-04-08Class II

ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC

Medline Industries, LP

Hazard

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.

Sold states

Worldwide - US Nationwide and the countries of Canada.

Affected count

651,789

Manufactured in

3 Lakes Dr, Northfield, IL, United States

Products

ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1690-2026

Original summary

ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC 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. UDI-DI 10888277314719 (ea) 40888277314710(case) All Lots Distribution: Worldwide - US Nationwide and the countries of Canada. Affected quantity: 651,789

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