Recalls / Class II
Class IID-0604-2018
Product
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.
- 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
- Lot #: a) 17KU03006, 7KU03007; b) 17KU03004, 17KU03005, Exp.08/2019
Why it was recalled
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
Recalling firm
- Firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 920 Winter St, N/A, Waltham, Massachusetts 02451-1521
Distribution
- Quantity
- 3,734 cases
- Distribution pattern
- Product was distributed throughout the United States to patients and clinics.
Timeline
- Recall initiated
- 2017-12-20
- FDA classified
- 2018-03-20
- Posted by FDA
- 2018-03-28
- Terminated
- 2019-02-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0604-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.