RecallRadar

FDA Drug recall D-0608-2024

DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx.…

On 2024-07-24 the FDA classified a Class II recall of DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx.… by Fresenius Medical Care Holdings, citing this product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0608-2024
ClassificationClass II
Statusongoing
Initiated2024-06-18
Published2024-07-24
Last updated2026-09-13 11:52 UTC
CompanyFresenius Medical Care Holdings
DistributionUS

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

This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.

Identifiers

ndc49230-206-92
ndc49230-206-94
ndc49230-206-95
ndc49230-209-92
ndc49230-209-94
ndc49230-209-95
ndc49230-212-92
ndc49230-212-94
ndc49230-212-95
code_info24AU03024, exp. date 07/31/2025

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0608-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.