Device product
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.
Z-0624-2016
Product summary
- Event
- Event 72701
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,484 pieces.
- Official record key
device-enforcement:Z-0624-2016
Official wording
Reason: Blood foaming was found during evaluation of the product.
Code information: Lot #'s 13E02, 13E03, 13E06, 13E07, 13E08,13E09, 13E10, 13G03, 13G11, 13G15, 14G24, 13G30, and 13H06.
Distribution pattern: US Distribution to states of: TN and NJ.
Derived failure modes
-
Unknown
Blood foaming was found during evaluation of the product.