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 vas…

Recall date

August 24, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0988-2017

FDA classification

Class II

Brand / firm

ICU Medical, Inc.

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.