Medline ENFit G-tube connector kits may leak from dimensional defect
Medline is recalling kits containing ENFit G-tube connectors because the connectors were not made to required dimensional specifications and may not form a proper seal.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: an out-of-specification feeding connector may leak and lead to delayed care or infection, and no injuries are stated.
Plain-English summary
Medline Industries, LP is recalling Medline kits containing ENFit G-tube connectors, covering the G/J Tube Care Kit (SKU DYKM2720) and the ENFit Discharge Kit (SKU ENFITDISCKIT). About 9,040 kits were distributed nationwide in the United States and to Canada. The FDA has classified this recall as Class II.
The 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 occur if the user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort and a prolonged recovery process.
All lots are affected, carrying UDI-DI 10198459016257 and 10193489860078.
Facilities can identify affected kits by the SKU and UDI above, and may contact Medline Industries, LP for further information.
The recalled product
- Product
- Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Enteral feeding
- Affected units
- 9,040
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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