NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx The NxStage PureFLow
FDA device recall Z-0826-2012 · posted 2012-01-20 · Terminated
Recall details
- Recalling firm
- NxStage Medical, Inc.
- Reason for recall
- Report of high conductivity failure alarms with the PureFlow SL due to excess concentrate by weight in the product (SAK) dialysate Preparation System
- Action taken
- On December 13, 2011, NxStage sent replacement product for overnight delivery and initiated phone contact with all consignees of the product . In addition, NxStage sent an "IMPORTANT MEDICAL DEVICE RECALL" notice dated December 14, 2011 to its consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to use SAKs from a different lot or premixed dialysate bags (RFPs), until their replacement SAKs arrived; set aside all SAKs from listed lot number; record their inventory; dispose of the SAKs following their normal practices, and complete and return the DEVICE PRODUCT RECALL REPLY FORM even if they do not have any of the affected product on hand via postage-prepaid envelop provided. If you have any questions about this notice, contact NxStage Customer Support at 866-Nxstage ( 697-8243).
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FKR
- Quantity affected
- 1,192 devices
- Distribution
- Nationwide distribution.
- Date initiated
- 2011-12-14
- Date posted
- 2012-01-20
- Date terminated
- 2012-04-17
- Location
- Lawrence, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NXSTAGE PUREFLOW SL (K111174) | Nxstage Medical, Inc. | 2011-09-19 |
| NXSTAGE PUREFLOW SL (K080919) | Nxstage Medical, Inc. | 2008-10-15 |