ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
Pending LLM rewrite. Source: FDA_DEVICE Z-1690-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 10888277314719 (ea) 40888277314710(case) All Lots
Distribution
Distributed nationwide across the United States.
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