FDA-Device2021-05-19Class II
REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
Hazard
Due 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.
Sold states
Worldwide 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.
Manufactured in
951 Calle Amanecer, San Clemente, CA, United States
Products
REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1565-2021More ICU Medical, Inc. recalls
- FDA-Device2026-06-17ICU Medical Plum Duo Precision IV Pump recalled for missing soft limit alerts
- FDA-Device2026-06-17ICU Medical Plum Duo Infusion Pump recalled for missing soft limit alerts
- FDA-Device2026-06-17ICU Medical Plum Solo Precision IV Pump recalled for missed soft limit alerts
- FDA-Device2026-05-27ICU Medical ChemoLock oncology infusion sets recalled for potential leakage during therapy
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