United StatesOncology Kit w/60" (152 cm), Approx 2.2 ml Smallbore Extension Set with ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros and Syringe Transfer Set with MicroClave, ChemoLock Port, REF: CL3960 (UDI-DI: 10887709083278; lots 13919794, 14134777, 14196319) distributed nationwide in the listed US states is affected. The kits were recalled because the sets/closed system transfer devices with extension sets may leak, which can delay or interrupt therapy, potentially resulting in the patient receiving less infusion solution than intended and possible exposure of hazardous substances to patient, caregiver, or pharmacy technician.
What's being recalled
Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960
Recalling firm: ICU Medical, Inc., San Clemente, CA, United States.
How to identify it
UDI-DI: 10887709083278. Lots: 13919794, 14134777, 14196319
The hazard
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of GA, MA, OH, NC, CA, ND, MI, TX, FL, AR, CT, PA, WA, WI, CO, VT, NY, NH, KY, IA, KS, AL, NM, IL, MO, NJ.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada