FDA-Device2021-02-17Class II
60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which 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).
Hazard
Due to the incorrect filter assembly.
Sold states
Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, CT, FL, ID, IL, LA, MA, MN, NC, NJ, NY, TN, TX, VA, WA and WV. The country of Belgium.
Affected count
Total Kits = 7,500 for all four lots
Manufactured in
951 Calle Amanecer, N/A, San Clemente, CA, United States
Products
60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which 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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0956-2021More ICU Medical, Inc. recalls
- FDA-Device2026-07-22ICU Medical Plum Duo Infusion Pump recalled for potential overdose risk
- FDA-Device2026-07-22ICU Medical Plum Solo Precision IV Pump v1.0.3 recalled for potential overdose risk
- 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
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