Z-3093-2026 Class II Ongoing
FDA device recall Z-3093-2026 was initiated by Fresenius Medical Care Renal Therapies Group, LLC on July 14, 2026 and is designated Class II. Reason for recall: Complaints of blue-green discoloration in product The recall status is ongoing. Affected quantity: 56,036 cs; 1,788 drums; 204 ea.
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2026
- Initiation Date
- July 14, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 56,036 cs; 1,788 drums; 204 ea
Product 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
Reason for Recall
Complaints of blue-green discoloration in product
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Mexico.
Code Information
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.