Recall Z-1876-2018 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Nipro Medical Corporation
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 phys
| Date | Dec 19, 2017 |
| Status | Terminated |
| Reason | There is a possibility of the heparin line is occluded. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 307,944 units. |
| Distribution | US Distribution to the states of : GA, NY, TN, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072024 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 Nipro Medical Corp., Oct 4, 2007 |