Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-0988-2017

August 24, 2016

Class II

Product summary

Firm
ICU Medical, Inc.
Event
Event 75093
Status
Terminated
Classification
Class II
Quantity
476,600 units
Official record key
device-enforcement:Z-0988-2017

Official wording

Reason: ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices.

Code information: 3239841 3239848 3244021 3244022 3244023 3244558 3244560 3246196 3254636 3255850 3258004 3258326 3258327 3260656 3261516 3261517 3265975 3268523 3269593 3269594 3275467 3278966 3278967 3224799

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices.