DELFLEX Peritoneal Dialysis Solution Recalled Due to Temperature Abuse
Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution (1.5% Dextrose with exchange set) distributed nationwide 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 involving potential temperature-related degradation of a drug product with no reported illnesses or injuries. The hazard is theoretical and based on exposure conditions rather than confirmed harm, meeting the criterion for a Low severity score.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling DELFLEX Peritoneal Dialysis Solution (containing dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride) with 1.5% Dextrose, low magnesium, and low calcium formulation, along with an attached stay-safe exchange set. The product is supplied in 2000 mL bags and administered intraperitoneal.
The recall has been issued because the product was exposed to temperatures outside specified limits during distribution or storage, which may affect the product's safety and efficacy.
The affected product is Lot #20SU02032 with an expiration date of July 2022, NDC 49230-206-92. The recall includes five cases distributed nationwide within the United States. Patients currently using this product or those who have this product on hand should contact their healthcare provider or Fresenius Medical Care for guidance on whether their product is affected and what steps to take.
The recalled product
- Product
- DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
- Brand
- DELFLEX
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- temperature-abuse
- product-degradation
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 #: 20SU02032
- Exp. date July 2022
Distribution
Distributed nationwide across the United States.
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