Recalls / Class II
Class IID-0608-2024
Product
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogenic, For Intraperitoneal Administration Only, Fresenius Medical Care NA Waltham, MA 02451, 1-800-323-5188 NDC 49230-212-94
- 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
- 24AU03024, exp. date 07/31/2025
Why it was recalled
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Recalling firm
- Firm
- Fresenius Medical Care Holdings, Inc.
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 920 Winter St Bld 920, Waltham, Massachusetts 02451-1521
Distribution
- Quantity
- 183 cases
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2024-06-18
- FDA classified
- 2024-07-17
- Posted by FDA
- 2024-07-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0608-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.