Official recall record
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-12-19
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00840619026059
- Brand on record
- ICU Medical, Inc.
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-05-12 · US FDA — Medical Devices
Plum administration sets - 2026-05-12 · US FDA — Medical Devices
Oncology sets with drip chambers - 2026-05-12 · US FDA — Medical Devices
IV Non-Dedicated Gravity Administration Sets with drip chambers
All 16 official recall notices naming ICU Medical, Inc. on this site →
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