Recall Z-0220-2021— ICU Medical, Inc.

Name: FDA recall Z-0220-2021
Creator: U.S. Food and Drug Administration
Published: 2020-07-06

Class II · Terminated

Class II FDA medical device recall by ICU Medical, Inc., initiated 2020-07-06, terminated 2023-05-11. It names one FDA 510(k) clearance: K080077. Product: Appx 0.82 ml, 3 Gang 4-Way NanoClave¿ Stopcock Manifold w/Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053189(17)241201(30)50(10)4537253;(01)10887709053189(17)250101(30)50(10)4557545. The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids that flow from a container to a patient's vascular system through a needle or catheter inserted into a vein or artery. This device is a four-way stopcock with an integral CLAVE side-port for closed, needleless access to the patient tubing or other fluid container.. Reason: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-07-06
Terminated: 2023-05-11
Firm location: San Clemente, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K080077 — CLAVE STOPCOCKIcu Medical, Inc.·cleared 2008-02-13

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

Appx 0.82 ml, 3 Gang 4-Way NanoClave¿ Stopcock Manifold w/Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053189(17)241201(30)50(10)4537253;(01)10887709053189(17)250101(30)50(10)4557545. The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids that flow from a container to a patient's vascular system through a needle or catheter inserted into a vein or artery. This device is a four-way stopcock with an integral CLAVE side-port for closed, needleless access to the patient tubing or other fluid container.

Reason for recall

Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

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