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U.S. Department of Health and Human Services

Class 2 Device Recall NxStage PureFlowB Solution

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  Class 2 Device Recall NxStage PureFlowB Solution see related information
Date Initiated by Firm March 18, 2013
Date Posted May 02, 2013
Recall Status1 Terminated 3 on September 17, 2014
Recall Number Z-1214-2013
Recall Event ID 64820
510(K)Number K042045  
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
Product 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.
Code Information F023444
Recalling Firm/
Manufacturer		 NxStage Medical, Inc.
350 Merrimack Street
Lawrence MA 01843-1748
For Additional Information Contact
866-697-8243
Manufacturer Reason
for Recall		 Product may be mislabeled.
FDA Determined
Cause 2		 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 recall call 1-866-697-8243.
Quantity in Commerce 1480 cases (2 bags per case)
Distribution Nationwide Distribution including IL, SC, TX, VA, FL, AR, and NY.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPO and Original Applicant = NXSTAGE MEDICAL, INC.
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