FDA Drug recall D-0604-2018
DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-…
- FDA Drug
- Class II
- terminated
- Published 2018-03-28
On 2018-03-28 the FDA classified a Class II recall of DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-… by Fresenius Medical Care Renal Therapies Group, citing lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0604-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-20 |
| Published | 2018-03-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fresenius Medical Care Renal Therapies Group |
| Distribution | US |
Product
DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451.
Reason
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
Identifiers
| ndc | 49230-206-30 |
|---|---|
| ndc | 49230-206-32 |
| ndc | 49230-206-50 |
| ndc | 49230-206-52 |
| ndc | 49230-206-62 |
| ndc | 49230-209-30 |
| ndc | 49230-209-32 |
| ndc | 49230-209-50 |
| ndc | 49230-209-52 |
| ndc | 49230-209-62 |
| ndc | 49230-212-30 |
| ndc | 49230-212-32 |
| ndc | 49230-212-50 |
| ndc | 49230-212-52 |
| ndc | 49230-212-62 |
| ndc | 49230-209-23 |
| code_info | Lot #: a) 17KU03006, 7KU03007; b) 17KU03004, 17KU03005, Exp.08/2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Fresenius Medical Care Renal Therapies Group
- CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors
FDA Device · Class II · 2026-09-30 · Fresenius Medical Care Renal Therapies Group - 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 1…
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group - GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B
FDA Device · Class II · 2026-09-09 · Fresenius Medical Care Renal Therapies Group
All Fresenius Medical Care Renal Therapies Group recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0604-2018%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.