Recall Z-1073-2014 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
NxStage Medical, Inc.
NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. The NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
| Date | Feb 24, 2014 (initiated Jan 24, 2014) |
| Status | Terminated |
| Reason | Mislabeled product. |
| Root cause | Packaging process control |
| Action | NxStage sent a Voluntary Medical Device Recall letter dated January 24, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were asked to check all boxes in inventory for the recalled lot and segregate and quarantine them. In addition, they were asked to complete the recall reply form and return it by fax to NxStage Medical as well as to contact NxStage Customer service to arrange for return of all affected product and for replacement to be sent. Distributor was asked to notify all downstream customers and t |
| Quantity | 969 cases (2 bags per case) |
| Distribution | US Distribution including the states of NY, TX, ID, AR, CA and AL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053286 | MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION Nxstage Medical, Inc., Dec 22, 2005 |