Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used
FDA device recall Z-2686-2014 · posted 2014-09-23 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- Product was held at temperature above the labeled recommended storage temperature
- Action taken
- Fresenius Medical North America contacted customers via telephone on 6/23/14 by Customer Service and follow-up with formal letter notification, Urgent Recall by certified mail with signature confirmation and faxback form Customers instructed to examine their inventory to determine whether they have any of the affected Naturalyte Liquid Bicarbonate. If customers have the affected product, they are instructed to contact FMC-RTG Customer Service to have the product replaced. A revised/clarification letter dated 7/10/14 issued to state only products from the identified lots that were delivered by RTG LLC to the specified facilities on May 5, 2014 are affected by this recall as products were exposed to temperatures higher than their recommended storage temperature during transportation on May 5, 2014. If you have any additional questions, please contact your FMCNA Customer Service Team at 1-800-323-5188.
- Root cause
- Storage
- Status
- Terminated
- Product code
- KPO
- Quantity affected
- 72 cases
- Distribution
- Distributed in Texas.
- Date initiated
- 2014-06-23
- Date posted
- 2014-09-23
- Date terminated
- 2021-01-29
- Location
- Waltham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB (K071387) | Fresenius Medical Care North America | 2007-06-15 |