Medline Industries, LP: ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medline Industries, LP
- Product
- ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide - US Nationwide and the countries of Canada.
- Recall initiated
- 2026-02-13
- Code info
- UDI-DI 10888277314719 (ea) 40888277314710(case) All Lots
- Product quantity
- 651,789
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northfield
- State
- IL
- Country
- United States
- Event id
- 98524
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