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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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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
Distribution Pattern Nationwide Distribution including IL, SC, TX, VA, FL, AR, and NY.

Product Detail

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