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Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conju...

FDA Recall #Z-0838-2021 — Class II — November 23, 2020

Recall #Z-0838-2021 Date: November 23, 2020 Classification: Class II Status: Ongoing

Product Description

Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Reason for Recall

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.

Recalling Firm

Fresenius Medical Care Holdings, Inc. — Waltham, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

912 cases

Distribution

US Nationwide distribution.

Code Information

Lot Numbers: 20LXAC088 Additional Affected lots as of 3/17/21: 20LXAC088 20LXAC052

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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