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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
E-Mail
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
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