Peritoneal Dialysis Solution Recalled for Lack of Sterility Assurance
Fresenius Medical Care is recalling 69,590 bags of DELFLEX Peritoneal Dialysis Solution due to lack of sterility assurance. The affected lot was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a high-risk product (peritoneal dialysis solution administered directly into the peritoneal cavity). No illnesses or injuries have been reported in the source text, but the lack of sterility assurance on a product for direct body cavity infusion presents a significant risk of harm.
Plain-English summary
Fresenius Medical Care Holdings, Inc. has recalled DELFLEX Peritoneal Dialysis Solution due to lack of sterility assurance. DELFLEX is a peritoneal dialysis solution used in kidney dialysis treatment. The product is supplied in 6000mL bags with 1.5% dextrose concentration and is for prescription use only.
The recall affects 69,590 bags with lot number 23JK02010 and expiration date January 31, 2025. The product was distributed nationwide within the United States. Peritoneal dialysis solutions are administered directly into the peritoneal cavity, where sterility is critical to prevent infection and other serious complications.
The recalled product
- Product
- DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
- Brand
- DELFLEX
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 69,590
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 (3)
- Part Number: 077-60621
- Lot #: 23JK02010
- Exp. Date 1/31/2025
Distribution
Distributed nationwide across the United States.
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Similar recalls
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