Z-0624-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 20, 2016
- Initiation Date
- March 30, 2015
- Termination Date
- February 4, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,484 pieces.
Product Description
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.
Reason for Recall
Blood foaming was found during evaluation of the product.
Distribution Pattern
US Distribution to states of: TN and NJ.
Code Information
Lot #'s 13E02, 13E03, 13E06, 13E07, 13E08,13E09, 13E10, 13G03, 13G11, 13G15, 14G24, 13G30, and 13H06.