NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indica
FDA device recall Z-1214-2013 · posted 2013-05-02 · Terminated
Recall details
- Recalling firm
- NxStage Medical, Inc.
- Reason for recall
- Product may be mislabeled.
- Action taken
- NxStage sent a letter dated March 18, 2013, via email to all consignees instructing them to check their entire inventory and to segregate and quarantine lot F023444 pending further instruction from NxStage. On 4/2/13 NxStage sent a letter via email to all consignees requesting a return of all RFP-400 and RFP-401 labeled with lot F023444.. Consignees were instructed to complete the recall reply form and provide a list of customers (name address, phone number) and fax them to NXStage Medical, Inc. Customers with questions were instructed to call 1-866-697-8243. For questions regarding this recall call 1-866-697-8243.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- KPO
- Quantity affected
- 1480 cases (2 bags per case)
- Distribution
- Nationwide Distribution including IL, SC, TX, VA, FL, AR, and NY.
- Date initiated
- 2013-03-18
- Date posted
- 2013-05-02
- Date terminated
- 2014-09-17
- Location
- Lawrence, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NXSTAGE PUREFLOW-B SOLUTION (K042045) | Nxstage Medical, Inc. | 2004-08-27 |