Why it was recalled
Lack of Sterility Assurance
Product description
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.
Lot numbers, UPCs & expiration codes
Part Number: 077-60621, Lot #: 23JK02010, Exp. Date 1/31/2025
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0218-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 28, 2023
- FDA report date
- Jan 10, 2024
- Quantity
- 69,590 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
Original FDA data
Every field from FDA enforcement report D-0218-2024, exactly as published.
Show all FDA fields
- City
- Waltham
- State
- MA
- Status
- Ongoing
- Country
- United States
- Event ID
- 93690
- Address
- 920 Winter St Bld 920
- Code information
- Part Number: 077-60621, Lot #: 23JK02010, Exp. Date 1/31/2025
- Postal code
- 02451-1521
- Report date
- Jan 10, 2024
- Product type
- Drugs
- Recall number
- D-0218-2024
- Classification
- Class II
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product quantity
- 69,590 bags
- Reason for recall
- Lack of Sterility Assurance
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Dec 28, 2023
- Initial firm notification
- Letter
- Center classification date
- Jan 4, 2024