Recalling firm
Fresenius Medical Care Holdings, Inc.
Product type
Drug
Status
Ongoing
Report date
2024-07-24
Distribution
Nationwide
Firm state
MA
Product quantity
183 cases
Initiated by
Voluntary: Firm initiated
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.
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
Code / lot info
24AU03024, exp. date 07/31/2025
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.