Fresenius Medical Care Holdings, Inc. recalls
8 recalls on record · 1 rated Critical · FDA
Every recall we have on record for Fresenius Medical Care Holdings, Inc., compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius…
Lack of Assurance of Sterility
RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model…
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Blood Pump Rotor, Model Number: F40015481 Rev A
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for…
Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during use of the Novalung system.
stay-safe /Luer Lock Adapter 4 in
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Stay Safe Cap
Updating the labeling to include additional warnings and contraindications for potential side effects.
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg,…
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number:…
Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock