FDAFDA · Food and drugs·Recall number Z-2723-2017
10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
Published July 19, 2017 · Recall initiated: May 30, 2017
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
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ICU Medical, Inc.
- Distributor
- Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
- Lot
- Lot No. 3182596, 3204086, 3246762, 3263682, 3295482. Item No. AM6109
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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