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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 Recall
NxStage PureFlowB Solution
see related information
Date Posted May 02, 2013
Recall Status1 Open
Recall Number Z-1214-2013
Recall Event ID 64820
Premarket Notification
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, Massachusetts 01843-1748
Manufacturer Reason
for Recall
Product may be mislabeled.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPO and Original Applicant = NXSTAGE MEDICAL, INC.
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