Recall Z-1723-2022— ICU Medical, Inc.

Name: FDA recall Z-1723-2022
Creator: U.S. Food and Drug Administration
Published: 2022-08-01

Class II · Ongoing

Class II FDA medical device recall by ICU Medical, Inc., initiated 2022-08-01. It names one FDA 510(k) clearance: K082806. Product: 6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.. Reason: Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-08-01
Firm location: San Clemente, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K082806 — SPINNING SPIROS, MODEL CH-2000Icu Medical, Inc.·cleared 2009-04-06

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

6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.

Reason for recall

Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.

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