FDA recall D-0608-2024

Fresenius Medical Care Holdings, Inc. · Class II · drug

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

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

Key facts

Status
Ongoing
Initiation date
2024-06-18
Report date
2024-07-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0608-2024