Fresenius Recalls Delflex Peritoneal Dialysis Solution Due to Labeling Error
Fresenius Medical Care is recalling 709 cases of Delflex Peritoneal Dialysis Solution because a 4.25% dextrose bag was found inside a 1.5% dextrose box.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling mix-up without reported injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Fresenius Medical Care, North America is recalling 709 cases of Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC. The product is packaged in a case containing 2 x 6 Liter bags and is available by prescription only. The recall involves Lot #20SU03019 with an expiration date of 6/2022.
The recall was initiated due to a labeling mix-up where a 4.25% dextrose bag was found inside a 1.5% dextrose box. This error could lead to the administration of the wrong concentration of dextrose to patients.
The affected product was distributed nationwide in the USA. Patients and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be stopped and returned to the distributor or manufacturer for credit.
The recalled product
- Product
- DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
- Brand
- DELFLEX
- Manufacturer
- Fresenius Medical Care, North America
- Hazard
- Affected units
- 709
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 (2)
- Lot #20SU03019
- Exp 6/2022
Distribution
Distributed nationwide across the United States.
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