Tego Connector, Item No. D1000, NM1000 recallZ-0988-2017 · ICU Medical, Inc. · initiated Aug 24, 2016
Class II Terminated All recalls posted in January 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ICU Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices.
FDA root cause category: Under Investigation by firm
What the company is doing
The firm, icumedical, sent an "URGENT: Medical Device Recall Notification" letter dated 8/24/16 to all their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to quarantine any affected devices; remove from use, return to ICU medical, Inc.; and complete and return the recall response form to ICU Medical via fax (801) 264-1755 or at [email protected] (even if you do not have any affected product). Customers with questions are instructed to contact ICU customer service Monday through Friday between 8:30AM and 4:00PM Pacific Time, (866) 829-9025 and select option 8 or email the following: [email protected].
Recall details
- Recall number
- Z-0988-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 24, 2016
- Posted by the FDA
- Jan 10, 2017
- Recalling firm
- ICU Medical, Inc.
- Quantity
- 476,600 units
- Product code
- FPA
- FDA submissions
- K053106
- Distribution
- Worldwide Distribution-US: (Nationwide) and countries of: Saudi Arabia, Germany, Austria, Belgium, Estonia, Poland, Switzerland, Canada, Luxembourg, Netherlands, Bulgaria, Malaysia, Italy, Ireland, Great Britain, France, Brazil, Sweden, Slovenia, and Portugal.
Product description
Tego Connector, Item No. D1000, NM1000 The Tego Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdrawal of fluids to a patient through a cannula or needle placed in the vein or artery. The Tego is a needle-free capping device which closes the end of the catheter. The Tego will permit access to the catheter without the use of needles and therefore passively aid in the reduction of needle stick injuries.
Code information (models, lots, serial numbers)
3239841 3239848 3244021 3244022 3244023 3244558 3244560 3246196 3254636 3255850 3258004 3258326 3258327 3260656 3261516 3261517 3265975 3268523 3269593 3269594 3275467 3278966 3278967 3224799
Other devices under the same FDA submission
2 devices cleared under K053106 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Tego™ D1000Icu Medical, Inc. · Set, administration, intravascular1 recall2 deaths655 reports
- Tego™ D1005Icu Medical, Inc. · Set, administration, intravascular31 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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