Recall Z-0511-2021— ICU Medical, Inc.

Name: FDA recall Z-0511-2021
Creator: U.S. Food and Drug Administration
Published: 2020-07-01

Class II · Terminated

Class II FDA medical device recall by ICU Medical, Inc., initiated 2020-07-01, terminated 2022-12-01. It names one FDA 510(k) clearance: K964435. Product: 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: Incorrect filter assemblies in IV administration set..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-07-01
Terminated: 2022-12-01
Firm location: San Clemente, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K964435 — PRIMARY IV SETIcu Medical, Inc.·cleared 1997-04-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.