WhichRecall
Class IIReported 2026-03-04

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

Recalled by Medline Industries, LP

Reason for Recall

Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits

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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.

Recall Number
Z-1464-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2026-01-08
Reported
2026-03-04
Distribution
US Nationwide distribution.
Code Info
UDI-DI (ea) 10653160373582 UDI-DI (case) 00653160373585 Kit lots 2024051380 2024052080 2024052180 2024052280 2024071580 2025061790 2025072990
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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