DELFLEX Peritoneal Dialysis Solution Recall for Temperature Exposure
Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose (5000 mL bags, 2-pack) due to temperature abuse during storage or transport that may have compromised product integrity.
What this means for you
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 for a drug product with a potential integrity issue caused by storage conditions. The source text does not report any illnesses, injuries, or deaths. The hazard is a precautionary concern about product quality rather than an active safety threat with documented harm, placing this in the Moderate category.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack (NDC 49230-0188-50) distributed nationwide in the United States. The recall affects Lot #20JU01001 with expiration date February 2022, totaling 25 cases.
The product was exposed to temperatures outside its specified storage limits. This temperature abuse may have affected the product's chemical or physical integrity, raising concerns about its safety and efficacy for peritoneal dialysis patients.
Patients and healthcare providers who have this product in stock should stop use immediately and contact Fresenius Medical Care for further instructions regarding return or replacement of the affected lot. Patients should consult their healthcare provider about alternative dialysis solutions.
The recalled product
- Product
- DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- temperature-exposure
- product-integrity
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 #: 20JU01001
- Exp. Date February 2022
Distribution
Distributed nationwide across the United States.
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