—#149342

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.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K053106
Affected lot / code info: 3239841 3239848 3244021 3244022 3244023 3244558 3244560 3246196 3254636 3255850 3258004 3258326 3258327 3260656 3261516 3261517 3265975 3268523 3269593 3269594 3275467 3278966 3278967 3224799

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The firm, icumedical, sent an "URGENT: Medical Device Recall Notification" letter dated 8/24/16 to all their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to quarantine any affected devices; remove from use, return to ICU medical, Inc.; and complete and return the recall response form to ICU Medical via fax (801) 264-1755 or at recall@icumed.com (even if you do not have any affected product). Customers with questions are instructed to contact ICU customer service Monday through Friday between 8:30AM and 4:00PM Pacific Time, (866) 829-9025 and select option 8 or email the following: customerservice@icumed.com.

Recalling firm

Firm: ICU Medical, Inc.
Address: 951 Calle, Amanecer San Clemente, California 92673-6212

Distribution

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.

Timeline

Recall initiated: 2016-08-24
Posted by FDA: 2017-01-10
Terminated: 2017-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #149342. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.