D-0608-2024 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- July 24, 2024
- Initiation Date
- June 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 183 cases
Product Description
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
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 Pattern
Nationwide
Code Information
24AU03024, exp. date 07/31/2025