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U.S. Department of Health and Human Services

Class 2 Device Recall Premixed Dialysate for Hemodialysis

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 Class 2 Device Recall Premixed Dialysate for Hemodialysissee related information
Date Initiated by FirmNovember 10, 2017
Create DateMarch 19, 2018
Recall Status1 Terminated 3 on December 06, 2019
Recall NumberZ-1132-2018
Recall Event ID 79276
510(K)NumberK053286 
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
ProductNxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
Code Information RFP-400 - M535RFP4000 RFP-400-BB - 00842289101258 RFP-401 M - 535RPF4010 RFP-401-BB - 00842289101265 RFP-402 - M535RFP4020 RFP-403 - M535RFP4030 RFP-404- M535RFP4040 RFP-405 - M535RFP4050 RFP-406 - M535RFP4060 RFP-453 - M535RFP4530 RFP-454 - M535RFP4540 RFP-455 - M535RFP4550 RFP-456 - M535RFP4560
FEI Number 3003464075
Recalling Firm/
Manufacturer		 NxStage Medical, Inc.
350 Merrimack Street
Lawrence MA 01843-1748
For Additional Information ContactTodd Snell
978-687-4700
Manufacturer Reason
for Recall		Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk. The NxStage PureFlow B Solution is for use with systems that use one premixed dialysate during hemodialysis. The original labeling did not warn against mixing dialysate formulations and did not instruct staff to verify that the fluid is flowing during use.
FDA Determined
Cause 2		Labeling design
ActionCustomers are advised to : 1. Always make sure when using PureFlow B Solution that fluid is flowing freely from all bags. 2. Recognize that any practice of hanging more than one fluid type at the same time is not an intended use of the NxStage System One" (as it does not monitor fluid composition) and is not a labeled indication of PureFlow B solutions. 3. Please make sure that all users of PureFlow B Solution in your organization and other concerned persons are informed regarding this Field Safety Notice. 4. Complete the enclosed customer reply form and return it to NxStage. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices.
Quantity in Commerce1243400 units
DistributionUS nationwide distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KPO
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