FDA-Device2026-03-04Class II

Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746

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

2020

Manufactured in

3 Lakes Dr, N/A, Northfield, IL, United States

Products

Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1464-2026

Original summary

Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746 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. UDI-DI (ea) 10653160373582 UDI-DI (case) 00653160373585 Kit lots 2024051380 2024052080 2024052180 2024052280 2024071580 2025061790 2025072990 Distribution: US Nationwide distribution. Affected quantity: 2020

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