Medline dialysis maintenance kits recalled for defective Tego Connector seals
What this means
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
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1465-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
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- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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