NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L b
FDA device recall Z-1073-2014 · posted 2014-02-24 · Terminated
Recall details
- Recalling firm
- NxStage Medical, Inc.
- Reason for recall
- Mislabeled product.
- Action taken
- NxStage sent a Voluntary Medical Device Recall letter dated January 24, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were asked to check all boxes in inventory for the recalled lot and segregate and quarantine them. In addition, they were asked to complete the recall reply form and return it by fax to NxStage Medical as well as to contact NxStage Customer service to arrange for return of all affected product and for replacement to be sent. Distributor was asked to notify all downstream customers and to provide NxStage Medical with a list of customers. Please complete and fax this form to 978-687-4810 even if you do not have any of the affected product on hand. 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
- Packaging process control
- Status
- Terminated
- Product code
- KPO
- Quantity affected
- 969 cases (2 bags per case)
- Distribution
- US Distribution including the states of NY, TX, ID, AR, CA and AL
- Date initiated
- 2014-01-24
- Date posted
- 2014-02-24
- Date terminated
- 2014-08-29
- Location
- Lawrence, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION (K053286) | Nxstage Medical, Inc. | 2005-12-22 |