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Medline Industries, LP: Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167

Medical DevicesSource: FDA (device) · Date: 2026-03-04

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medline Industries, LP
Product
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2026-01-08
Code info
UDI-DI (ea) 10195327015954 UDI-DI (case) 40195327015955 Kit lots 24IME953 25CMA708
Product quantity
150
Voluntary mandated
Voluntary: Firm initiated
City
Northfield
State
IL
Country
United States
Event id
98333
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