DELFLEX Peritoneal Dialysis Solution Recalled for Temperature Abuse
Fresenius Medical Care is recalling 285 cases of DELFLEX Peritoneal Dialysis Solution nationwide because the product was exposed to temperatures outside specified limits during distribution.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: This is an FDA Class III recall involving a precautionary measure for potential temperature-related product degradation. No illness or injury has been reported, and the hazard is a theoretical risk from temperature exposure rather than confirmed contamination or defect. Class III recalls typically receive a score of 1 or 2; the moderate score reflects the critical nature of the affected product (peritoneal dialysis solution for vulnerable patients) despite the absence of reported harm.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low Magnesium, Low Calcium, supplied in 3000 mL bags and 5000 mL bags (2 packs). A total of 285 cases have been recalled nationwide.
The recall affects specific lot numbers: 20SU03060 (3000 mL bags, expiration July 2022) and 21AU02015 and 21AU02038 (5000 mL bags, expiration August 2022). The product was exposed to temperatures outside its specified storage limits during distribution.
Peritoneal dialysis solutions are prescription medications administered intraperitoneally for patients with kidney disease. Exposure to improper temperatures may affect the product's stability and safety. Patients currently using DELFLEX should contact their healthcare provider or dialysis center for guidance. Healthcare providers should quarantine affected lots and contact Fresenius Medical Care for instructions on handling and replacement.
The recalled product
- Product
- DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
- Brand
- DELFLEX
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 285
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 (5)
- Lot #: a) 20SU03060
- Exp Date. July 2022
- b) 21AU02015
- 21AU02038
- Exp. Date August 2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
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