Naturalyte Liquid Acid concentrate drums recall
Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - 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: 20LXAC066 20LXAC089 Additional Affected lots as of 3/17/21: 20LXAC066 20LXAC073 20LXAC074 20LXAC024 20LXAC023 20LXAC072 20LXAC085 20LXAC089
- Product
- Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium…
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 2 drums
- Distribution
- US Nationwide distribution.
- Recall date
- January 20, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)