Naturalyte Liquid Acid concentrate bottles recall
Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium…
Why was Naturalyte Liquid Acid concentrate bottles recalled?
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 20LXAC058 20LXAC078 20LXAC096 20NXAC011 20NXAC012 Additional Affected lots as of 3/17/21: 20LXAC060 20NXAC026 20LXAC045 20LXAC043 20LXAC078 20NXAC012 20LXAC058 20LXAC096 20NXAC011 20LXAC059 20LXAC044 20LXAC079
- Product
- Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium…
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 5079 cases
- Distribution
- US Nationwide distribution.
- Recall date
- January 20, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)