Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000

FDA device recall Z-1111-2026 · posted 2026-01-16 · Open, Classified

Recall details

Recalling firm

ICU Medical, Inc.

Reason for recall

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

Action taken

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.custhelp.com For further inquiries, please contact the firm: Global Complaint Management: productcomplaintspp@icumed.com 1-(866)-216-8806; Customer Service: customerservice@icumed.com, 1-(800)-258-5361

Root cause

Process control

Status

Open, Classified

Product code

FPA

Quantity affected

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

Date initiated

2025-12-19

Date posted

2026-01-16

Location

San Clemente, CA

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