Medline dialysis dressing change kits recalled for defective Tego Connectors
What this means
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
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-1468-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- 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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