Bicarby Dialysate; Model number: RFP-400-G;
Fresenius Medical Care Holdings, Inc.
The hazard
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. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Bicarby Dialysate; Model number: RFP-400-G;
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model Model number: RFP-400-GModel UDI-DI: 00840861102839Model Lot codes: 25SG06026Model 25SG06027UPC 00840861102839Would you have heard about this one?
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