Fresenius Recalls DELFLEX Peritoneal Dialysis Solution Due to Bag Leakage
Fresenius Medical Care is recalling specific lots of DELFLEX Peritoneal Dialysis Solution because bag leakage may compromise sterility.
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: The recall is classified as FDA Class II and involves a risk of harm (loss of sterility) for a high-risk patient population, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 3,734 cases of DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag. The affected product is a prescription-only intraperitoneal solution packaged in 3L and 2L single bags. The recall is due to a lack of assurance of sterility caused by leakage of the peritoneal dialysis solution bag.
The affected lots are 17KU03006, 7KU03007, 17KU03004, and 17KU03005, all with an expiration date of 08/2019. The product was distributed throughout the United States to patients and clinics. The NDCs for the affected packaging are 49230-209-30 and 49230-209-23.
Patients and clinics should stop using the affected product and contact their healthcare provider or the manufacturer for instructions on replacement or disposal. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
- Brand
- DELFLEX
- Affected units
- 3,734
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 (5)
- Lot #: a) 17KU03006
- 7KU03007
- b) 17KU03004
- 17KU03005
- Exp.08/2019
Distribution
Distribution scope not specified by the agency.
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