Recall Weekly
Moderate riskFDA DeviceClass II

Fresenius Citrasate Liquid Acid Concentrate recalled for blue-green discoloration

Fresenius Medical Care has recalled specific lots of Citrasate Liquid Acid Concentrate used in hemodialysis due to blue-green discoloration observed in the product. The discoloration may indicate a quality issue that could affect the product's safety or efficacy. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Fresenius Medical Care recalls

What to do

  1. Check if your facility uses Citrasate with product numbers 08-2251-CA, 08-3251-CA, or 13-2251-CA and lot numbers 26BXAC038, 26BXAC039, 26BXAC040, or 26BXAC041.
  2. Do not use product showing blue-green discoloration.
  3. Contact Fresenius Medical Care for instructions on product return or replacement.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis
Sold in
Nationwide
Made for
Adults

This recall covers 3 products — see all of them.

Details

Units affected
56,036 cs; 1,788 drums; 204 ea
Illnesses reported
None reported
Manufactured in
920 Winter St Bld 920, N/A, Waltham, MA, United States
Classification
Class II
Recall number
Z-3093-2026

In the FDA's words

Description
Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis Complaints of blue-green discoloration in product 1) 08-2251-CA, UDI/DI 00840861101344, Lot Numbers: 26BXAC038; 2) 08-3251-CA, UDI/DI 00840861101351, Lot Numbers: 26BXAC039; 3) 13-2251-CA, UDI/DI 00840861101375, Lot Numbers: 26BXAC040, 26BXAC041. Distribution: Worldwide distribution - US Nationwide and the country of Mexico. Affected quantity: 56,036 cs; 1,788 drums; 204 ea
Hazard
Complaints of blue-green discoloration in product

3 products in this recall

GRANUFLO, NaturaLyte and Citrasate recalled for blue-green discoloration

Fresenius Medical Care is recalling three dialysis acid concentrate products, GRANUFLO, NaturaLyte and Citrasate, after complaints of blue-green discoloration in the product. No injuries have been reported. The products were distributed nationwide in the US and in Mexico.

The agency lists each product separately. Check every one you might have.

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