NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-305 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1 Chloride 100, Glucose (mg/dL) 100 Batch Size (liters) 40
- Company
- Nxstage Medical, Inc.
- Recall Initiated
- May 14, 2014
- Posted
- June 24, 2014
- Terminated
- March 13, 2017
- Recall Number
- Z-1858-2014
- Quantity
- 2839 cases
- Firm Location
- Lawrence, MA
Reason for Recall
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.
Lot / Code Info
Lot codes: 40179026 3057901 3047930
Root Cause
Material/Component Contamination
Action Taken
NxStage issued Initial recall letter dated 5/14/14 to dialysis centers. An error was noted and an updated letter dated 5/15/14 was resent to dialysis centers. The updated 5/15/14 letter was emailed to all current active PureFlow SL patients who had provided an email address followed by UPS next business day letter sent to all current active PureFlow SL patients. Accounts are requested to examine inventory and remove product. 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 at 1-866-NXSTAGE (1-866-697-8243).