NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
- Company
- Nxstage Medical, Inc.
- Recall Initiated
- October 17, 2018
- Terminated
- August 26, 2020
- Recall Number
- Z-0504-2019
- Quantity
- 114777
- Firm Location
- Lawrence, MA
Reason for Recall
PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
Distribution
US Nationwide Distribution.
Lot / Code Info
Lot Numbers: F1708230, F1708231, F1708234, F1708235, F1708237, F1708245, F1708246, F1708247, F1708250, F1708251, F1708253, F1708254, F1708256, F1709260, F1709261, F1709267, F1710327, F1710328, F1711343, F1711344, F1711345, Q1711844, Q1711853, Q1711854, Q1711855, Q1712025, Q1712091, Q1712092, Q1712137, Q1801146, Q1801147, Q1801148, Q1801149, Q1801151, Q1801202, Q1801221, Q1801225, Q1801226, Q1801335, Q1801336, Q1801337, Q1801338, Q1801339, Q1801340, Q1802507, Q1802508, Q1802509, Q1802510, Q1802511, Q1802512, Q1803685, Q1803686, Q1803687, Q1803690, Q1803750, Q1803754, Q1803755, Q1803774, Q1803775, Q1803776, Q1803847, Q1803848, Q1803849, Q1804888
Root Cause
Packaging process control
Action Taken
NxStage initiated a recall on October 17, 2018 via " URGENT MEDICAL DEVICE REMOVAL" Recall Notice to its customers. The notice provided reason for recall, health risk, action to be taken. The customers were instructed to do the following: 1 Check all boxes in your Pureflow B solution inventory, separate them from your other inventory and do not use them. 2. Follow the instructions on the attached reply form or click on the following link to respond electronically, https://www.nxstage.com/rfprecalloct2018, to acknowledge your receipt of this notice. 3. Contact NxStage Customer Service to arrange for return of all affected product and for replacement product to be sent, If you have any questions or comments, please feel free to contact NxStage Customer Service 1-866- NXST AGE (1-866-697-8243).