FDA recall Z-2809-2018

Product

PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave Manifold w/NanoClave (Purple Rings), Check Valve, Rotating Luer.

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-2809-2018