Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Pending LLM rewrite. Source: FDA_DEVICE Z-1111-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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
The recalled product
- Product
- Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 00840619026059
- 00840619006785. REF/Lot(Expiration): 011-D1000/14015455(5/1/2029)
- 14044313(6/1/2029)
- 14228823(12/1/2029)
- 14274294(1/1/2030)
- 01C-D1000/14171414(10/1/2029)
- 14304670(2/1/2030)
- 055-D1000/13772668(9/1/2028)
- 13778926(9/1/2028)
- 13791786(10/1/2028)
- 13794986(10/1/2028)
- 13797963(10/1/2028)
- 13801102(10/1/2028)
- 13806764(10/1/2028)
- 13812991(11/1/2028)
- 13822705(11/1/2028)
- 13828556(11/1/2028)
- 13833879(11/1/2028)
- 13838937(12/1/2028)
- 13867515(1/1/2029)
Distribution
Distributed nationwide across the United States.
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