ICU Medical, Inc. recalls Tego Connector, Item No. D1000, NM1000 The Tego¿ Needle Free Access Device is intended for use as an accessory to a v

Recalled January 18, 2017 · FDA recall Z-0988-2017 · ICU Medical

Hazard

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

Units

476,600 units

Sold at

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.

Description

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

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.

Manufacturer(s)

ICU Medical, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →