FDA-Device2026-03-04Class IIPROCESSING DEFECT

Medline dialysis dressing change kits recalled for defective Tego Connectors

Nationwide distribution

Stop using Medline dialysis dressing change kits

Medline dialysis dressing change convenience kits (SKU DYNDC3167) may contain defective Tego Connectors with silicone seal problems. The seals can dome or tear, which may block fluid flow, cause therapy delays, leak fluids, or allow air or contamination into the bloodstream.

  • Stop using kits from lots 24IME953 and 25CMA708
  • Contact Medline Industries for instructions on replacement or return
  • Contact your healthcare provider if you have questions about your dialysis care
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
150
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1468-2026

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