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U.S. Department of Health and Human Services

Class 2 Device Recall Tego Connector

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  Class 2 Device Recall Tego Connector see related information
Date Initiated by Firm August 24, 2016
Date Posted January 10, 2017
Recall Status1 Terminated 3 on July 07, 2017
Recall Number Z-0988-2017
Recall Event ID 75093
510(K)Number K053106  
Product Classification Set, administration, intravascular - Product Code FPA
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.
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
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
For Additional Information Contact
949-366-2183
Manufacturer Reason
for Recall		 ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices.
FDA Determined
Cause 2		 Under Investigation by firm
Action 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = ICU MEDICAL, INC.
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