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.
What this means for you
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.
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