FDA Recall D-0218-2024
Fresenius Medical Care Holdings, Inc. · Waltham, MA
Class II Ongoing 868 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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.
Reason for recall
Lack of Sterility Assurance
Recall record
- Recall number
D-0218-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the United States
- Recall initiated
- 2023-12-28
- Classified by FDA Center
- 2024-01-04
- FDA published
- 2024-01-10
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Firm location
- Waltham, MA
Drug identification
- Brand name(s)
- DELFLEX
- Generic name(s)
- DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE
- Manufacturer(s)
- Fresenius Medical Care Renal Therapies Group, LLC
- NDC(s)
49230-206, 49230-209, 49230-212- Route(s)
- INTRAPERITONEAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.