Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
30" (76 cm) Appx 6.3 ml Recalled by ICU Medical, Inc. Due to ICU Medical has identified an issue with a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ICU Medical, Inc. directly.
Affected Products
30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. 011-CL3528 sterile devices intended for the infusion and withdrawal of fluids.
Quantity: 50 units
Why Was This Recalled?
ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.
Where Was This Sold?
This product was distributed to 15 states: AZ, CA, CO, CT, DE, FL, IL, MA, MI, MO, NV, NJ, OH, TX, VA
About ICU Medical, Inc.
ICU Medical, Inc. has 592 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report