FDA-Device2026-03-04Class IIPROCESSING DEFECT

Medline dialysis on/off kits with Tego Connectors recalled for defective silicone seals

OTHERNationwide distribution

Stop using Medline dialysis on/off kits (SKU EBSI1746)

Medline dialysis on/off kits may contain Tego Connectors with defective silicone seals that can dome or tear. This can block the fluid path, prevent blood product injection or withdrawal, cause fluid leakage, delay treatment, or allow air or contaminants into the body.

  • Check if you have kit SKU EBSI1746 with a lot number matching 2024051380, 2024052080, 2024052180, 2024052280, 2024071580, 2025061790, or 2025072990
  • Stop using affected kits immediately
  • Contact Medline Industries for instructions on replacement or disposal
Hazard

Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.

Sold states
US Nationwide distribution.
Affected count
2020
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1464-2026

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