Medline ENFit G-tube connectors may leak from dimensional specification failure
Medline is recalling ENFit G-tube connectors because they were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices.
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 the ENFit G-Tube Connector, item number ENFIT1010GC. About 651,789 units 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 10888277314719 for each and 40888277314710 for the case.
Facilities can identify affected connectors by the item number and UDI above, and may contact Medline Industries, LP for further information.
The recalled product
- Product
- ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Enteral feeding
- Affected units
- 651,789
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.
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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