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Open, Classified

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

FDA Recall Z-1111-2026 · Posted 2026-01-16

Recalling FirmICU Medical, Inc.
Recall StatusOpen, Classified
Product CodeFPA
Date Initiated2025-12-19
Product Quantity14,684,607 items

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

Firm 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 [email protected] For further inquiries, please contact the firm: Global Complaint Management: [email protected] 1-(866)-216-8806; Customer Service: [email protected], 1-(800)-258-5361

Root Cause

Process control

Distribution Pattern

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, LK, MY, AT, FI, GB, TW, MX, NL, IE, CA, GR, ZA, SE, SK, NZ, LT, CH, HR, FR, JO, PE, SG, BR, PL, RO, HU, CZ, NO, AE, EE, CN, MA, HK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K053106TEGO, MODEL D1000Icu Medical, Inc. · 2006-01-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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