Recall Z-1719-2022— ICU Medical, Inc.

Name: FDA recall Z-1719-2022
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: K100434. Product: MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery.. 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

K100434 — CLAVE NEUTRONIcu Medical, Inc.·cleared 2010-07-09

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

MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery.

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.