Bicarby Dialysate Recall Issued Over GTIN Labeling Error
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Fresenius Medical Care Holdings, Inc. is recalling 4,752 units of Bicarby Dialysate (model RFP-400-G) distributed in Texas due to an error in GTIN labeling.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 27, 2026 and geographically references Texas. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, devices.
What Happened
Fresenius Medical Care Holdings, Inc. initiated a voluntary recall of Bicarby Dialysate after discovering an error in the GTIN labeling on the product. The case labeling, lot number, and printed labeling on the product correctly identify the product code and solution. If the incorrect GTIN is used as the sole source for identification, there is a risk of unrecognized use of a potassium solution with a concentration differing from the prescription.
Which Products Are Affected
The recall affects Bicarby Dialysate, model number RFP-400-G, UDI-DI 00840861102839. Affected lot codes are 25SG06026 and 25SG06027. A total of 4,752 units were distributed domestically in Texas.
What You Should Do
Consumers and facilities should verify product identification using the case labeling, lot number, or printed labeling on the product rather than relying solely on the GTIN scan. Contact the recalling firm for further instructions on returns or refunds.
Why This Matters
The labeling discrepancy could lead to use of an incorrect potassium concentration if GTIN data is the only identification method relied upon.
Source
FDA recall number Z-2401-2026; Class II recall initiated May 7, 2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,218 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 27, 2026.
Frequently Asked Questions
Common questions about this FDA recall.