Bicarby dialysate bags carry an incorrect GTIN on the label
Bicarby Dialysate, model RFP-400-G, is being recalled because of an error in the GTIN printed on the product, which could lead to a potassium concentration differing from the prescription.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where a scanning error could lead to a dialysate potassium concentration differing from the prescription, a risk of harm with no injuries reported.
Plain-English summary
Bicarby Dialysate, model number RFP-400-G, UDI-DI 00840861102839, from Fresenius Medical Care Holdings, Inc., is being recalled. The action covers 4,752 units in lot codes 25SG06026 and 25SG06027.
There is an error in the labeling of the GTIN on the product when scanned. According to the manufacturer, the case labeling, lot number and printed labeling on the product correctly identify the product code and the solution contained in the bag, but 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. The FDA classified the action as Class II.
Distribution was within the United States, in Texas. The dialysate is supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the model number, UDI-DI and lot codes above and follow the instructions issued by Fresenius Medical Care.
The recalled product
- Product
- Bicarby Dialysate; Model number: RFP-400-G;
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Medical Device — Dialysate
- Affected units
- 4,752
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model number: RFP-400-G
- UDI-DI: 00840861102839
- Lot codes: 25SG06026
- 25SG06027
Distribution
Distributed in 1 state:
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