NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-304 Lactate 45, Potassium 2, Sodium 140,
FDA device recall Z-1857-2014 · posted 2014-06-24 · Terminated
Recall details
- Recalling firm
- NxStage Medical, Inc.
- Reason for recall
- SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
- 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).
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- FKR
- Quantity affected
- 16,625 cases
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.
- Date initiated
- 2014-05-14
- Date posted
- 2014-06-24
- Date terminated
- 2017-03-13
- Location
- Lawrence, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NXSTAGE PUREFLOW SL (K140571) | Nxstage Medical, Inc. | 2014-05-15 |
| NXSTAGE PUREFLOW SL (K111174) | Nxstage Medical, Inc. | 2011-09-19 |