FDAFDA · Food and drugs·Recall number Z-2808-2018
40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
Published August 22, 2018 · Recall initiated: March 1, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ICU Medical de Mexico, S.A. de C.V.
- Distributor
- US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
- Lot
- Item Number011-AM6126. a. Lot Number 3409000, UDI Number (01) 1 0840619 09534 2 (17) 220201 (30) 50 (10) 3409000, Expiration Date 02/01/2022; b. Lot Number 3446970, UDI Number (01) 1 0840619 09534 2 (17) 220201 (30) 50 (10)3446970, Expiration Date 05/01/2022
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Mexico
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