Medline Industries recalled 651,789 ENFIT G-TUBE connectors (ENFIT1010GC) sold worldwide, including the United States and Canada. The connectors were not manufactured to required dimensional specifications and may not seal properly with ENFit-style devices, which could lead to leakage. Healthcare facilities and patients should stop using this device immediately and follow recall instructions from
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter
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These connectors are used to attach ENFit-compatible G-tube feeding devices in clinical settings. They facilitate enteral feeding in patients with GI access.
If the connector does not seal properly, fluids can leak, potentially delaying care and causing infection or patient discomfort. Over-tightening to stop leaks can worsen outcomes.
This recall is not described as part of a broader industry pattern in the provided data.
Hospitals and clinics may need to quarantine affected inventory, notify staff, and coordinate with Medline for replacements or refunds. The issue could affect patient care timelines.
Recall letter from Medline and the FDA enforcement page linked in the recall notice.
Not specified in the recall notice.
Document recall references, catalog numbers, lot numbers, dates, and all correspondence with Medline.
Item: ENFIT G-TUBE CONNECTOR ENFIT1010GC. Distribution: Worldwide, including US and Canada. Class II recall. Quantity: 651,789 units. Model/UDI: UDI-DI 10888277314719 (ea) 40888277314710 (case) All Lots. Brand: Medline Industries, LP.
No injuries or incidents have been reported.
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