20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system.
FDA Recall Z-2797-2018 · Posted None
Recalling FirmICU Medical de Mexico, S.A. de C.V.
Recall StatusTerminated
Product CodeFMG
Date Initiated2018-03-01
Date Terminated2024-01-26
Product Quantity81 pouches
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.
Firm Action
ICU Medical notified customers of the recall on about 03/01/2018 via URGENT: Medical Device Recall Notification. The notification informed customers that this was an update and expansion to previously initiated recall. Instructions included to inspect inventory for affected devices, arrange for the return of affected devices, and complete and return the Urgent Medical Device Recall Notification Response Form to [email protected].
Root Cause
Other
Distribution Pattern
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.