PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: December 9, 2020 Initiated: July 1, 2020 #Z-0511-2021

Product Description

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.

Reason for Recall

Incorrect filter assemblies in IV administration set.

Details

Recalling Firm
ICU Medical, Inc.
Units Affected
1100 units
Distribution
U.S. Nationwide distribution including in the states of WI, MA, CA, FL, MN, IL, NY.
Location
San Clemente, CA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by ICU Medical, Inc.. Units affected: 1100 units.
Why was this product recalled? ▼
Incorrect filter assemblies in IV administration set.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 9, 2020. Severity: Moderate. Recall number: Z-0511-2021.

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