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ICU Medical, Inc. Recall 87703

Description: REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

ICU Medical, Inc. Recall 87703 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1573-2021
Event ID87703
Event DescriptionREF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Product TypeDevices
DistributionWorldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA and WA. The countries of Belgium, Canada, France, Italy, South Africa, Spain, United Kingdom.
Recall ReasonDue to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Device Classification20210519
Device Code InfoREF: CL3946 UDI: (01) 1 0887709 08029 1 (17) 260101 (30) 50 (10) 5142959 Lot Number: 5142959
Center Classification Date20210513
Recall Initiation Date20210316
Recalling FirmICU Medical, Inc.
Initial Notification Letter
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