HIGH
FDA DEVICE
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
Fresenius Medical Care Holdings
Given the
Brand hub
Fresenius Medical Care Holdings Recalls
5 recalls found for Fresenius Medical Care Holdings. Check current safety alerts and related brands before using affected products.
- Active recalls
- 5
- Pages
- 1
HIGH
HIGH
FDA DRUG
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North...
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Fresenius Medical Care Holdings
Lack of
HIGH
FDA DRUG
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North...
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Fresenius Medical Care Holdings
Lack of
Health & Personal Care
HIGH
FDA DEVICE
Fresenius Medical Care Optiflux Dialyzers Recalled for Press-On Cap Issue (172,494,732 units, 2025)
To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.
Fresenius Medical Care Holdings
To provide
Brand Statistics
Total Recalls
5
Pages
1