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FDA-Device2026-03-04Class II

Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200

Medline Industries, LP
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

Original summary

Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200 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. IR PACK UDI-DI (ea) 10195327621780 UDI-DI (case) 40195327621781 Kit lots 24BBP627 24DBO029 24FBI148 24JBA858 24KBD925 24LBG978 25ABQ002 25EBV162; NO CATHETER DIALYSIS INSERTION UDI-DI (ea) 10195327675219 UDI-DI (case) 40195327675210 Kit Lots 24EBM915 24GBC287 Distribution: US Nationwide distribution. Affected quantity: 516

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