Fresenius Medical Care Holdings, Inc. — Class II: Bicarby Dialysate; Model number: RFP-400-G;
Fresenius Medical Care Holdings, Inc. initiated a Class II recall for Bicarby Dialysate (Model RFP-400-G) due to an error in the Global Trade Item Number (GTIN) labeling. While case and lot labeling are correct, the GTIN scan identifies the product incorrectly.
This affects Fresenius Medical Care Holdings, Inc., healthcare providers using Bicarby Dialysate Model RFP-400-G, and logistics personnel relying on automated identification systems.
The error creates a risk of using dialysate with a potassium concentration different from the patient's prescription if the GTIN is the sole source of identification. This highlights potential vulnerabilities in automated clinical workflows and inventory management when digital identifiers do not align with human-readable packaging.
QA teams should verify that GTIN barcodes match human-readable product codes and physical contents. Staff utilizing barcode-driven inventory or administration systems should be cautioned against relying solely on electronic scans for product identification until labeling accuracy is confirmed.
Class II. Reason: There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.. Product: Bicarby Dialysate; Model number: RFP-400-G;. Firm: Fresenius Medical Care Holdings, Inc. (Waltham MA United States). Status: Ongoing.
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