Why it was recalled
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
Product description
DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451.
Lot numbers, UPCs & expiration codes
Lot #: a) 17KU03006, 7KU03007; b) 17KU03004, 17KU03005, Exp.08/2019
Where it was sold
Product was distributed throughout the United States to patients and clinics.
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-0604-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 20, 2017
- FDA report date
- Mar 28, 2018
- Quantity
- 3,734 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
Original FDA data
Every field from FDA enforcement report D-0604-2018, exactly as published.
Show all FDA fields
- City
- Waltham
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 79403
- Address
- 920 Winter St
- Code information
- Lot #: a) 17KU03006, 7KU03007; b) 17KU03004, 17KU03005, Exp.08/2019
- Postal code
- 02451-1521
- Report date
- Mar 28, 2018
- Product type
- Drugs
- Recall number
- D-0604-2018
- Classification
- Class II
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Product quantity
- 3,734 cases
- Termination date
- Feb 14, 2019
- Reason for recall
- Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451.
- Distribution pattern
- Product was distributed throughout the United States to patients and clinics.
- Recall initiation date
- Dec 20, 2017
- Initial firm notification
- Letter
- Center classification date
- Mar 20, 2018