Recall Z-2717-2017— ICU Medical, Inc.

Name: FDA recall Z-2717-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-30

Class II · Terminated

Class II FDA medical device recall by ICU Medical, Inc., initiated 2017-05-30, terminated 2024-09-20. It names one FDA 510(k) clearance: K964435. Product: 168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, MicroClave¿ Clear, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).. Reason: The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-05-30
Terminated: 2024-09-20
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

168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, MicroClave¿ Clear, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

Reason for recall

The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.

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