ICU Medical recalls Tego Connectors with specific model numbers due to risk of silicone seal bulging, tearing, leading to fluid leaks, blood product injection issues, or exposure to contaminants during hemodialysis.
Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body
ICU Medical recalls Tego Connectors (model numbers listed) because their silicone seal can bulge or tear, potentially causing fluid leaks, interrupted therapy, or exposure to biological contaminants. This affects medical devices used in hemodialysis or intravascular treatments.
The silicone seal in the connector may bulge at the top, separate from the device body, or tear. This can cause fluid leaks, block blood flow, delay treatments, or expose users to biological contaminants like blood or pathogens.
Healthcare professionals using these connectors for hemodialysis or intravascular treatments are most at risk. Patients receiving dialysis or blood products through these devices could face complications.
Check for model numbers: 011-D1000, 01C-D1000, 055-D1000, D1000, or LAT-D1000. These connectors are used with hemodialysis or intravascular administration sets.
Look for model numbers on the connector: 011-D1000, 01C-D1000, 055-D1000, D1000, or LAT-D1000.
Reach out to ICU Medical for guidance on next steps if you have a recalled connector.
The silicone seal may bulge, separate, or tear, causing fluid leaks, blocked blood flow, delayed treatments, or exposure to biological contaminants.
Check the model number on the connector: 011-D1000, 01C-D1000, 055-D1000, D1000, or LAT-D1000.
Contact ICU Medical for instructions on next steps; they will guide you on whether to stop using or replace the connector.
We’ve drafted a message you can send Tego to request your refund or repair — edit it as you like.
Subject: Recall Z-1111-2026 — Tego Tego Hello, I own a Tego that is covered by recall Z-1111-2026 from Tego. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
