Recall Z-2811-2018— ICU Medical de Mexico, S.A. de C.V.

Name: FDA recall Z-2811-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-01

Class II · Terminated

Class II FDA medical device recall by ICU Medical de Mexico, S.A. de C.V., initiated 2018-03-01, terminated 2024-01-26. It names one FDA 510(k) clearance: K964435. Product: 61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext.. Reason: ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold..

Recalling firm: ICU Medical de Mexico, S.A. de C.V.
Classification: Class II
Status: Terminated
Initiated: 2018-03-01
Terminated: 2024-01-26
Firm location: Ejido Maneadero, Mexico

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

61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext.

Reason for recall

ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.

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