Recalls / Class II
Class IID-0389-2021
Product
Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60, Fresenius Medical Care North America, 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 #20SU03019, Exp 6/2022
Why it was recalled
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Recalling firm
- Firm
- Fresenius Medical Care, North America
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 475 W 13th St, N/A, Ogden, Utah 84404-5554
Distribution
- Quantity
- 709 cases
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2021-04-14
- FDA classified
- 2021-05-19
- Posted by FDA
- 2021-05-26
- Terminated
- 2022-04-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0389-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.