Date Initiated by Firm | May 14, 2014 |
Date Posted | June 24, 2014 |
Recall Status1 |
Terminated 3 on March 13, 2017 |
Recall Number | Z-1857-2014 |
Recall Event ID |
68354 |
510(K)Number | K111174 K140571 |
Product Classification |
Dialysate Subsystem, proportioning - Product Code FKR
|
Product | NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-304
Lactate 45, Potassium 2, Sodium 140, Calcium 3,Magnesium 1,
Chloride 101, Glucose (mg/dL) 100
Batch Size (liters) 60
The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStage PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch. |
Code Information |
Lot code: 40179091 40179069 40179068 40179029 40179019 31279094 3067901 3057932 3057919 3057918 3057909 3057908 |
Recalling Firm/ Manufacturer |
NxStage Medical, Inc. 350 Merrimack Street Lawrence MA 01843-1748
|
For Additional Information Contact | 978-687-4700 |
Manufacturer Reason for Recall | SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification |
FDA Determined Cause 2 | Material/Component Contamination |
Action | 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). |
Quantity in Commerce | 16,625 cases |
Distribution | Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = FKR
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