Device product
Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. The Nipro¿ Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient s blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.
Z-1876-2018
Product summary
- Event
- Event 79834
- Status
- Terminated
- Classification
- Class II
- Quantity
- 307,944 units.
- Official record key
device-enforcement:Z-1876-2018
Official wording
Reason: There is a possibility of the heparin line is occluded.
Code information: Model No. BL+A223D/V809D, Vendor Batch No. 17I06-9, 17I16-9, 17I18-9, 17J17-9, 17J19-9 , 17J20-9 , 17J21-9, 17I19-9, 17K07-9 , 17I01-9, 17J12-9, 17J16-9, 17I21-9, 17I25-9, 17I26-9, 17J09-9, 17J11-9, 17K15-9, 17K16-9.
Distribution pattern: US Distribution to the states of : GA, NY, TN, TX.
Derived failure modes
-
Unknown
There is a possibility of the heparin line is occluded.