Fresenius Medical Naturalyte Acid Concentrate for bicarbonate Dialysis 45x , 55 gallons (208.2 Liters) Cat. No. 13-2251-
FDA device recall Z-1612-2012 · posted 2012-05-15 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- Sodium content does not meet product requirements
- Action taken
- Fresenius Medical Care North America sent an "URGENT PRODUCT RECALL" letter dated March 28, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to examine their stock immediately to determine whether they have any affected product. A fax back form was included for customers to complete and return. Contact FMCNA Customer Service Team at 1-800-323-5188 for questions regarding this notice.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KPO
- Quantity affected
- 154 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2012-03-16
- Date posted
- 2012-05-15
- Date terminated
- 2014-01-28
- Location
- Waltham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL (K981043) | Solution Technologies | 1998-05-26 |