NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
FDA device recall Z-0181-2023 · posted 2022-11-04 · Open, Classified
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free.
- Action taken
- On October 4, 2022, the firm notified affected customers via Important Medical Device Information letters. Customers were reassured that the product was manufactured according to specification and remains potassium-free. Customers may continue to use the product. Please contact FMCRTG Customer Service at 1-800-323-5188 if you have further questions.
- Root cause
- Error in labeling
- Status
- Open, Classified
- Product code
- KPO
- Quantity affected
- 17700
- Distribution
- Domestic distribution to AL AZ CA DC FL GA HI IL IN MD MI MO MS NE NJ NY OH PA SD TX VA No foreign distribution.
- Date initiated
- 2022-10-04
- Date posted
- 2022-11-04
- Location
- Waltham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES (K070177) | Fresenius Medical Care North America | 2007-03-29 |