FDA-Drug2024-07-24Class II
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
Fresenius Medical Care Holdings, Inc.
Hazard
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Sold states
Nationwide
Affected count
183 cases
Manufactured in
920 Winter St Bld 920, Waltham, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0608-2024Don't want to check this manually?
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