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.
FDA Recall Z-1214-2013 · Posted 2013-05-02
Advertisement
Recalling FirmNxStage Medical, Inc.
Recall StatusTerminated
Product CodeKPO
Date Initiated2013-03-18
Date Terminated2014-09-17
Product Quantity1480 cases (2 bags per case)
Reason for Recall
Product may be mislabeled.
Firm 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 recall call 1-866-697-8243.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution including IL, SC, TX, VA, FL, AR, and NY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement