FDAFebruary 25, 2016device
110" (279 cm) Appx 13.8 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Clave, Rotating Luer, Bag Hanger, Item No. AHCL3300 sterile devices intended for the infusion and withdrawal of fluids.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
icu medicalicu
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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