FDAFDA · Food and drugs·Recall number Z-0624-2016
NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. Compatible for use with Fresenius 2008H, 2008K/K2 and 2008T dialysis machines.
Published January 20, 2016 · Recall initiated: March 30, 2015
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
Blood foaming was found during evaluation of the product.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Nipro Medical Corporation
- Distributor
- US Distribution to states of: TN and NJ.
- Lot
- Lot #'s 13E02, 13E03, 13E06, 13E07, 13E08,13E09, 13E10, 13G03, 13G11, 13G15, 14G24, 13G30, and 13H06.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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