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Fresenius Medical Care Renal Therapies Group, LLC: Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentr

Medical DevicesSource: FDA (device) · Date: 2026-09-09

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Fresenius Medical Care Renal Therapies Group, LLC
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
Reason / hazard
Complaints of blue-green discoloration in product
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the country of Mexico.
Recall initiated
2026-07-14
Code info
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.
Product quantity
56,036 cs; 1,788 drums; 204 ea
Voluntary mandated
Voluntary: Firm initiated
City
Waltham
State
MA
Country
United States
Event id
99543
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