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Recall Observatory FDA recall evidence

Device product

28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer.

Z-2804-2018

March 01, 2018

Class II

Product summary

Firm
ICU Medical de Mexico, S.A. de C.V.
Event
Event 80460
Status
Terminated
Classification
Class II
Quantity
74 pouches
Official record key
device-enforcement:Z-2804-2018

Official wording

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.

Code information: Item Number 011-AM6116. a. Lot Number 3380551, UDI Number (01) 1 0840619 09274 7 (17) 211201 (30) 50 (10) 3380551, Expiration Date 12/01/2021; b. Lot Number 3493462, UDI Number (01) 1 0840619 09274 7 (17) 220701 (30) 50 (10) 3493482, Expiration Date 07/01/2022

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.