Z-0988-2017Class II

Tego Connector, Item No. D1000, NM1000 The Tego Needle Free Access Device is intended for use as an accessory...

Name: Z-0988-2017 Tego Connector, Item No. D1000, NM1000 The Tego Needle Free Access Device is intended for use as an accessory...
Creator: ICU Medical, Inc.
Published: 2016-08-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2016-08-24 / Terminated

FDA source

ICU Medical, Inc. began a recall of 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... on 2016-08-24. FDA classified it as Class II and gives the reason as "ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0988-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-24
Posted: 2017-01-10
Terminated: 2017-07-07
Recalling firm: Abbott Medical
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.
Product code: FPA Set, Administration, Intravascular
Reason for recall: ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices.
FDA root cause: 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 [email protected] (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: [email protected].
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.
Product codes and lots: 3239841 3239848 3244021 3244022 3244023 3244558 3244560 3246196 3254636 3255850 3258004 3258326 3258327 3260656 3261516 3261517 3265975 3268523 3269593 3269594 3275467 3278966 3278967 3224799

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0988-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0988-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-10

Product code FPA

K053106Class IITego, Model D1000Icu Medical, Inc. / cleared 2006-01-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)