DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM… — Class II drug recall D-0608-2024
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2024-07-24, distributed nationwide. This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficul
| Recall number | D-0608-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2024-06-18 |
| Classified | 2024-07-17 |
| Reported by FDA | 2024-07-24 |
| Distributed | Nationwide (US) |
| Quantity | 183 cases |
| Reason classes | packaging |
| NDC | 49230-0206, 49230-0206-92, 49230-0206-94, 49230-0206-95, 49230-0209, 49230-0209-92, 49230-0209-94, 49230-0209-95, 49230-0212, 49230-0212-92, 49230-0212-94, 49230-0212-95 |
| Expiration dates | 2025-07-31 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0608-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.