Recall Z-2799-2018— ICU Medical de Mexico, S.A. de C.V.

Name: FDA recall Z-2799-2018
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: 30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.. 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

30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.

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.