Recall Z-0988-2017 ยท FPA Set, Administration, Intravascular
ICU Medical, Inc.
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
| Date | Jan 10, 2017 (initiated Aug 24, 2016) |
| Status | Terminated |
| Reason | ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices. |
| 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 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) |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053106 | TEGO, MODEL D1000 Icu Medical, Inc., Jan 10, 2006 |