Naturalyte Liquid Acid concentrate drums recall
Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium…
Why was Naturalyte Liquid Acid concentrate drums 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: 20LXAC025 20LXAC081 20LXAC082 20LXAC083 Additional Affected lots as of 3/17/21: 20LXAC029 20NXAC021 20LXAC026 20LXAC065 20LXAC028 20NXAC029 20LXAC071 20LXAC103 20LXAC027 20LXAC070 20LXAC067 20NXAC019 20LXAC082 20LXAC025 20LXAC081 20LXAC083
- Product
- Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium…
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 224 drums
- Distribution
- US Nationwide distribution.
- Recall date
- January 20, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)