FDA-Device2026-03-04Class IIPROCESSING DEFECT

Medline dialysis maintenance kits recalled for defective Tego Connector seals

OTHERNationwide distribution

Stop using affected Medline dialysis kits

Medline dialysis kits containing Tego Connectors may have defective silicone seals that can dome or tear. This can block the fluid path, prevent blood withdrawal, cause fluid leaks, interrupt treatment, or allow air and contaminants into the body.

  • Check if your dialysis kit matches one of the recalled products and lot numbers listed by the FDA
  • Stop using affected kits immediately
  • Contact your dialysis center or Medline for a replacement kit
  • Do not attempt to use a kit with a damaged or leaking connector
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
14,525
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI4310A Medline DIALYSIS CAP CHANGE KIT SKU DYNDC2425 Medline DIALYSIS CHANGE KIT SKU EBSI1453A Centurion HEMODIALYSIS ACCESS KIT SKU DT12970 Medline LARGE BORE, DIALYSIS, ENHANCED SECUREMENT SKU EBSI1741

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1465-2026

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