FDAFDA · Food and drugs·Recall number Z-0681-2014
6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector w/Luer Slip, Part No. A1000, Item No. K7085-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
Published January 15, 2014 · Recall initiated: December 24, 2013
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 recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ICU Medical, Inc.
- Distributor
- Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.
- Lot
- Lot No. 2767357
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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