Recalls / Class II
Class IID-0218-2024
Product
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.
- Brand name
- Delflex
- Generic name
- Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride
- Active ingredients
- Calcium Chloride, Dextrose Monohydrate, Magnesium Chloride, Sodium Chloride, Sodium Lactate
- Route
- Intraperitoneal
- NDCs
- 49230-206, 49230-209, 49230-212
- FDA application
- NDA020171
- Affected lot / code info
- Part Number: 077-60621, Lot #: 23JK02010, Exp. Date 1/31/2025
Why it was recalled
Lack of Sterility Assurance
Recalling firm
- Firm
- Fresenius Medical Care Holdings, Inc.
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 920 Winter St Bld 920, N/A, Waltham, Massachusetts 02451-1521
Distribution
- Quantity
- 69,590 bags
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-12-28
- FDA classified
- 2024-01-04
- Posted by FDA
- 2024-01-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0218-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.