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.
This recall has been terminated (originally issued May 2, 2013).
- Company
- Nxstage Medical, Inc.
- Recall Initiated
- March 18, 2013
- Posted
- May 2, 2013
- Terminated
- September 17, 2014
- Recall Number
- Z-1214-2013
- Quantity
- 1480 cases (2 bags per case)
- Firm Location
- Lawrence, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Product may be mislabeled.
Distribution
Nationwide Distribution including IL, SC, TX, VA, FL, AR, and NY.
Lot / Code Info
F023444
Root Cause
Labeling mix-ups
Action Taken
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 recall call 1-866-697-8243.