FDARecall

[Recall] — Convenience kits used for dial — Affected lots may exhibit issues with th

Feb 24, 2026

Published: 2026-02-24Captured: 2026-03-01Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI431...Product Code: LRO

FDA device recall (Open, Classified). : Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tea.

•Status: Open, Classified
•Root cause: Process control
•Action: On January 8, 2026, the firm notified affected customers of the product issue through email and f...

Reason

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 fl...

Root Cause:Process control

Action

On January 8, 2026, the firm notified affected customers of the product issue through email and first class mail. Customers were instructed to request stickers to over-label affected convenience ki...

Status:Open, Classified

Distribution:US Nationwide distribution.

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