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.
Recall
- Recall Number
- Z-1876-2018
- Event Number
- 79834
- Firm
- Nipro Medical Corporation
- FEI Number
- 1000132332
- Product Code
- FJK
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- December 19, 2017
- Terminated
- October 19, 2021
- Address
- 3150 NW 107th Ave, Doral, FL, 33172-2135
Description
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.
There is a possibility of the heparin line is occluded.
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.
US Distribution to the states of : GA, NY, TN, TX.
307,944 units.