FDAFDA · Food and drugs·Recall number Z-2810-2018
38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), 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 Number 011-AM6132. a. Lot Number 3484175, UDI Number (01) 1 0840619 09743 6 (17) 220601 (30) 50 (10) 3484175, Expiration Date 07/01/2022; b. Lot Number 3493946, UDI Number (01) 1 0840619 09743 6 (17) 220701 (30) 50 (10) 3493946, Expiration Date 07/01/2022; c. Lot Number 3498103, UDI Number (01) 1 0840619 09743 6 (17) 220701 (30) 50 (10) 3498103, Expiration Date 07/01/2022
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Mexico
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