Recall Z-1111-2026 ยท FPA Set, Administration, Intravascular
ICU Medical, Inc.
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
| Date | Jan 16, 2026 (initiated Dec 19, 2025) |
| Status | Open, Classified |
| Reason | Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body |
| Root cause | Process control |
| Action | On 12/19/2025, correction notices were emailed to customers who were asked to do the following: 1) Destroy all affected products following your institution's process for destruction. If destroying is not immediately possible at your facility, then the product should be quarantined until disposal. 2) Share this notification with all potential users of the device, to ensure they are aware of this notification. If the devices are used at another location, please ensure this communication is delivered there. 3) Complete and return the Customer Response Form via email to marketaction@mailac.cust |
| Quantity | 14,684,607 items |
| Distribution | Worldwide - US Nationwide distribution including in the states of FL, AZ, RI, TN, KS, NJ, NY, VA, SC, GA, CA, MS, TX, OH, NC, MA, WA, IL, PA, NV, NH, LA, MI, NE, ME, MN, NM, OK, MD, IA, OR, SD, WI, MO, AL, WY, IN, KY, DC, UT, AR, WV, AK, ND, CO and the countries of BE, DE, CO, ES, AU, AR, SA, SI, IT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053106 | TEGO, MODEL D1000 Icu Medical, Inc., Jan 10, 2006 |