FDA-Device2026-03-04Class IIPROCESSING DEFECT

Medline dialysis insertion kits recalled for defective Tego Connectors

OTHERNationwide distribution

Stop using affected Medline dialysis kits

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
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
516
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1463-2026

More Medline Industries, LP recalls

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief