[pending] ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
Pending LLM rewrite. Source: FDA_DEVICE Z-1690-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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