Recall Z-1721-2022— ICU Medical, Inc.

Name: FDA recall Z-1721-2022
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: K964435. Product: 6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;. 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

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

6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;

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.