DELFLEX Peritoneal Dialysis Solution Recalled for Temperature Abuse Exposure
Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution (Lot #20PU04030, 4 cases) distributed nationwide because the product was exposed to temperatures outside specified limits, which may affect safety and efficacy.
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 pharmaceutical product subject to storage requirements. The source text states only a condition (temperature exposure) without reporting any confirmed illnesses, injuries, or safety failures. No deaths or serious adverse events are documented. Per the rubric, Class III recalls with no reported harm are typically scored 1–2; a manufacturing/storage defect elevates this to Moderate (2).
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose (Low Magnesium, Low Calcium formulation) in 2000 mL packs with attached stay-safe exchange sets. The recall affects 4 cases with Lot #20PU04030 and expiration date June 2022 that were distributed nationwide in the United States.
The product is being recalled because it was exposed to temperatures outside the specified storage limits. Temperature abuse can compromise the integrity and safety of the dialysis solution, potentially affecting its intended therapeutic use.
Patients and healthcare providers who have received this lot should stop using the affected product. Individuals with questions about this recall should contact Fresenius Medical Care or consult their healthcare provider. Healthcare facilities should identify and quarantine affected inventory by lot number and report its status to the manufacturer.
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
- 4
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 #: 20PU04030
- Exp. date June 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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