Recall Z-0624-2016 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Nipro Medical Corporation
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.
| Date | Jan 8, 2016 (initiated Mar 30, 2015) |
| Status | Terminated |
| Reason | Blood foaming was found during evaluation of the product. |
| Root cause | Device Design |
| Action | NIPRO contacted their consignees by email 9/25/2013 of the affected product. Customers were instructed to return product back to Nipro Medical Warehouse or discard at point of use. Please contact Director of QA/RA at Nipro Medical Corporation for any additional information or return correspondence to JessicaO@nipromed.com / 305.599.7174x249. |
| Quantity | 1,484 pieces. |
| Distribution | US Distribution to states of: TN and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112628 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET Nipro Medical Corporation, Sep 28, 2012 |