Recall Z-0663-2019— ICU Medical, Inc.

Name: FDA recall Z-0663-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-05

Class II · Terminated

Class II FDA medical device recall by ICU Medical, Inc., initiated 2018-10-05, terminated 2021-03-25. It names one FDA 510(k) clearance: K884318. Product: Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645. Reason: Potential for leakage due to defect in the thermoset check valve component..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-10-05
Terminated: 2021-03-25
Firm location: San Clemente, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K884318 — THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEMAbbott Laboratories·cleared 1988-12-13

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

Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645

Reason for recall

Potential for leakage due to defect in the thermoset check valve component.

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