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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Product Detail

Product Description 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.
Recall Number Z-1214-2013
Classification Class II
Code Info F023444
Product Distributed Qty 1480 cases (2 bags per case)
Reason For Recall Product may be mislabeled.

Event Detail

Event Id 64820
Product Type Devices
Status Ongoing
Recalling Firm NxStage Medical, Inc.
City Lawrence
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-18
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Nationwide Distribution including IL, SC, TX, VA, FL, AR, and NY.
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