FDA recall Z-2798-2018

ICU Medical de Mexico, S.A. de C.V. · Class II · device

Product

165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, 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.

Distribution

US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.

Key facts

Status
Terminated
Initiation date
2018-03-01
Report date
2018-08-22
Termination date
2024-01-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ejido Maneadero, Mexico

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2798-2018