Drug 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
D-0608-2024
Product summary
- Event
- Event 94887
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 183 cases
- Official record key
drug-enforcement:D-0608-2024
Official wording
Reason: This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Code information: 24AU03024, exp. date 07/31/2025
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.