FDAHealthJune 18, 2024
Fresenius Medical Care Holdings, Inc. — DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single
⚠️ This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 18, 2024
Nationwide
What's affected?
- 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
- DELFLEX
- Lot code
- 24AU03024, exp. date 07/31/2025
Additional details
24AU03024, exp. date 07/31/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 183 cases.
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