Recall Z-1722-2022— ICU Medical, Inc.

Name: FDA recall Z-1722-2022
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: K970855. Product: MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. 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

K970855 — CLAVE CONNECTORIcu Medical, Inc.·cleared 1997-06-24

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; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. 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.