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Recall Observatory FDA recall evidence

Device product

6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.

Z-2816-2018

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
300 pouches
Official record key
device-enforcement:Z-2816-2018

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 AM6130. a. Lot Number 3414534, UDI Number (01) 1 0887709 08771 9 (17) 220201 (30) 50 (10) 3414534, Expiration Date 02/01/2022; b. Lot Number 3442461, UDI Number (01) 1 0887709 08771 9 (17) 220501 (30) 50 (10) 3442461, Expiration Date 05/01/2022; b. Lot Number 3509517, UDI Number (01) 1 0887709 08771 9 (17) 220801 (30) 50 (10) 3509517, Expiration Date 08/01/2022

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.