FDA-Device2026-03-04Class II

Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167

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

150

Manufactured in

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

Products

Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1468-2026

Original summary

Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167 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) 10195327015954 UDI-DI (case) 40195327015955 Kit lots 24IME953 25CMA708 Distribution: US Nationwide distribution. Affected quantity: 150

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