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.
This recall has been terminated (originally issued December 19, 2017).
- Company
- Nipro Medical Corporation
- Recall Initiated
- December 19, 2017
- Terminated
- October 19, 2021
- Recall Number
- Z-1876-2018
- Quantity
- 307,944 units.
- Firm Location
- Doral, FL
- Official Source
- View on FDA website ↗
Reason for Recall
There is a possibility of the heparin line is occluded.
Distribution
US Distribution to the states of : GA, NY, TN, TX.
Lot / Code Info
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.
Root Cause
Process control
Action Taken
Customers were notified on approximately December 19, 2017, via letter. Instructions included to place affected lots on hold and to advise Nipro if any affected product has been further distributed. If affected product has been further distributed, Nipro advised the customer to notify those customers and have the product returned immediately. Additionally Nipro requested that they complete and return the response form to arrange for product return. For further questions, please call (305) 599-7174.