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Recall Observatory FDA recall evidence

Device product

10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer.

Z-2812-2018

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
200 pouches
Official record key
device-enforcement:Z-2812-2018

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 AM6100. a. Lot Number 3373756, UDI Number (01) 1 0887709 07066 7 (17) 211201 (30) 50 (10) 3373756, Expiration Date 12/01/2021; b. Lot Number 3423328, UDI Number (01) 1 0887709 07066 7 (17) 211401 (30) 50 (10) 3423328, Expiration Date 04/01/2022; c. Lot Number 3446319, UDI Number (01) 1 0887709 07066 7 (17) 211501 (30) 50 (10) 3446319, Expiration Date 05/01/2022

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.