PlainRecalls
FDA Devices Moderate Class II Terminated

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 needle

Reported: January 18, 2017 Initiated: August 24, 2016 #Z-0988-2017

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.

Reason for Recall

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

Details

Recalling Firm
ICU Medical, Inc.
Units Affected
476,600 units
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.
Location
San Clemente, CA

Frequently Asked Questions

What product 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.. Recalled by ICU Medical, Inc.. Units affected: 476,600 units.
Why was this product recalled? ▼
ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 18, 2017. Severity: Moderate. Recall number: Z-0988-2017.

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