ICU Medical, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0988-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 24, 2016

Date Posted: January 18, 2017

Recall Number: Z-0988-2017

Event ID: 75093

Reason for Recall:

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

Status: Terminated

Product Quantity: 476,600 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated