RecallRadar

FDA Device recall Z-3093-2026

Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA

On 2026-09-09 the FDA classified a Class II recall of Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA by Fresenius Medical Care Renal Therapies Group, citing complaints of blue-green discoloration in product.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-3093-2026
ClassificationClass II
Statusongoing
Initiated2026-07-14
Published2026-09-09
Last updated2026-09-15 05:30 UTC
CompanyFresenius Medical Care Renal Therapies Group
DistributionUS

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

Complaints of blue-green discoloration in product

Identifiers

code_info
1) 08-2251-CA, UDI/DI 00840861101344, Lot Numbers: 26BXAC038; 2) 08-3251-CA, UDI/DI 00840861101351, Lot Numbers: 26B…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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-15 05:30 UTC. Current status: ongoing.

Other recalls by Fresenius Medical Care Renal Therapies Group

All Fresenius Medical Care Renal Therapies Group recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3093-2026%22

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