Class II
Ongoing
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
This recall is currently active, issued July 24, 2024. It was issued by Fresenius Medical Care Holdings, Inc..
- Recall Initiated
- June 18, 2024
- Posted
- July 24, 2024
- Recall Number
- D-0608-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 183 cases
- Firm Location
- Waltham, MA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Distribution
Nationwide
Lot / Code Info
24AU03024, exp. date 07/31/2025
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