Medline dialysis insertion kits recalled for defective Tego Connectors
What this means
Medline Industries is recalling two dialysis insertion kits that contain Tego Connectors with defective silicone seals. The seals may dome or tear, which can block fluid flow, cause therapy delays, allow leaks, or introduce air or contamination into the body.
- Check if you have Medline IR Pack (SKU DYNJ67205C) or NO CATHETER DIALYSIS INSERTION (SKU CVI5200) kits
- Verify the kit lot number against the recall list (IR Pack lots: 24BBP627, 24DBO029, 24FBI148, 24JBA858, 24KBD925, 24LBG978, 25ABQ002, 25EBV162; Dialysis lots: 24EBM915, 24GBC287)
- Stop using recalled kits immediately
- Contact Medline or your healthcare provider for replacement kits
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-1463-2026More 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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