Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-13
FDA device recall Z-1826-2012 · posted 2012-06-25 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- Risk of Alkalosis with acetate containing dialysis acid concentrates
- Action taken
- Fresenius Medical Care sent an "IMPORTANT PRESCRIBING INFORMATION" letter dated March 29, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Reply Form was enclosed for customers to complete and return via fax to 781-699-9635. Contact Customer Service at 1-800-323-5188 or Medical Information at 1-855-616-2309 for questions regarding this recall.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- KPO
- Distribution
- Nationwide Distribution and the country of Guam.
- Date initiated
- 2012-03-29
- Date posted
- 2012-06-25
- Date terminated
- 2017-07-20
- 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 GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES (K030497) | Fresenius Medical Care | 2003-05-20 |