Recall Z-0957-2021— ICU Medical, Inc.

Name: FDA recall Z-0957-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-02

Class II · Terminated

Class II FDA medical device recall by ICU Medical, Inc., initiated 2020-12-02, terminated 2023-06-30. It names one FDA 510(k) clearance: K964435. Product: 7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - 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).. Reason: Due to the incorrect filter assembly..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-12-02
Terminated: 2023-06-30
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

7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - 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).

Reason for recall

Due to the incorrect filter assembly.

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