United StatesMedline’s ENFit G‑Tube Connector (Item No. ENFIT1010GC) and Medline kits that contain it (SKU DYKM2720 G/J TUBE CARE KIT and SKU ENFITDISCKIT ENFIT DISCHARGE KIT; UDI‑DI 10888277314719/10198459016257/10193489860078 and associated case UDI‑DIs) are being recalled. The connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit‑style devices, which can cause leakage and could lead to delayed care, fluid loss, additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery.
What's being recalled
ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT
Recalling firm: Medline Industries, LP, Northfield, IL, United States.
How to identify it
UDI-DI 10888277314719 (ea) 40888277314710(case) All Lots 1. UDI-DI 10198459016257 (ea) 40198459016258 (case) 2. UDI-DI 10193489860078 (ea) 40193489860079 (case) ALL LOTS
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide and the countries of Canada.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)