FDA-Device2020-12-09Class II
REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blue, Yellow, White), Rotating Luer - 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 catheter (which is inserted into a vein). Directions for Use: icumedical IV Exten
ICU Medical, Inc.
Hazard
Incorrect filter assemblies in IV administration set.
Sold states
U.S. Nationwide distribution including in the states of WI, MA, CA, FL, MN, IL, NY.
Affected count
1100 units
Manufactured in
951 Calle Amanecer, N/A, San Clemente, CA, United States
Products
REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blue, Yellow, White), Rotating Luer - 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 catheter (which is inserted into a vein). Directions for Use: icumedical IV Extension Sets Clave/MicroClave/NanoClave Connectors Antimicrobial Clave/MicroClave Connectors Spiros Closed Male Luer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0511-2021Don't want to check this manually?
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