DELFELX Peritoneal Dialysis Solution Recalled Due to Temperature Abuse
Fresenius Medical Care is recalling 49 cases of DELFELX Peritoneal Dialysis Solution (5000 mL, 4.25% Dextrose) because the product was exposed to temperatures outside specified limits.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is temperature exposure—a storage condition issue—with no evidence of resulting patient harm or clinical failure.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 49 cases of DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, in 5000 mL bags (NDC 49230-0212-50) distributed nationwide within the United States.
The recall was initiated because the product was exposed to temperatures outside the specified storage limits. The affected lots are #21AK01022 (expiration July 2022) and #20SK01022 (expiration June 2022).
Patients currently using this product should consult their healthcare provider for guidance. Fresenius Medical Care and healthcare facilities have been notified of this recall.
The recalled product
- Product
- DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-0212-50
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 49
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)
- Lot #: 21AK01022
- Exp. date July 2022
- 20SK01022
- 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
Same manufacturer · Fresenius Medical Care Holdings, Inc.
See all →- Moderate5008X Blood Tubing Set connection errors FDA Class II recall
FDA (Devices) · 2026-07-15
- HighBicarby dialysate bags carry an incorrect GTIN on the label
FDA (Devices) · 2026-06-17
- HighBicarby dialysate luer-lock connections may leak fluid onto floors
FDA (Devices) · 2026-06-17
- SevereDELFLEX Peritoneal Dialysis Solution Recall Due to Potential Sterility Issues
FDA (Drugs) · 2026-05-13
- HighDELFLEX Peritoneal Dialysis Solution bags recalled for sterility risk
FDA (Drugs) · 2026-05-13
Same hazard · temperature abuse
See all →- SevereKayem Foods Recalls Ready-to-Eat Meat and Poultry Due to Temperature Abuse
USDA FSIS · 2026-10-17
- ModerateZoladex Goserelin Implant Recalled Due to Temperature Abuse
FDA (Drugs) · 2026-10-07
- ModerateGemcitabine Injection Recalled Due to Temperature Storage Abuse
FDA (Drugs) · 2026-07-08
- ModerateChristopher Ranch peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
- ModerateGarland Fresh peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
Similar recalls
- ModerateFresenius Recalls Delflex Peritoneal Dialysis Solution Due to Labeling Error
FDA (Drugs) · 2021-05-26
- SevereDELFLEX Peritoneal Dialysis Solution Recall Due to Potential Sterility Issues
FDA (Drugs) · 2026-05-13
- HighDELFLEX Peritoneal Dialysis Solution bags recalled for sterility risk
FDA (Drugs) · 2026-05-13
- HighFresenius Recalls DELFLEX Peritoneal Dialysis Solution Due to Bag Leakage
FDA (Drugs) · 2018-03-28
- HighPeritoneal Dialysis Solution Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2024-01-10
- HighPeritoneal Dialysis Solution Recalled for Tube Weld Failure Risk
FDA (Drugs) · 2024-07-24