Recall Z-1214-2013 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
NxStage Medical, Inc.
NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
| Date | May 2, 2013 (initiated Mar 18, 2013) |
| Status | Terminated |
| Reason | Product may be mislabeled. |
| Root cause | Labeling mix-ups |
| Action | NxStage sent a letter dated March 18, 2013, via email to all consignees instructing them to check their entire inventory and to segregate and quarantine lot F023444 pending further instruction from NxStage. On 4/2/13 NxStage sent a letter via email to all consignees requesting a return of all RFP-400 and RFP-401 labeled with lot F023444.. Consignees were instructed to complete the recall reply form and provide a list of customers (name address, phone number) and fax them to NXStage Medical, Inc. Customers with questions were instructed to call 1-866-697-8243. For questions regarding this re |
| Quantity | 1480 cases (2 bags per case) |
| Distribution | Nationwide Distribution including IL, SC, TX, VA, FL, AR, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042045 | NXSTAGE PUREFLOW-B SOLUTION Nxstage Medical, Inc., Aug 27, 2004 |