Overview of recall records associated with Fresenius Medical Care Holdings, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 80, Class III: 6.
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
(1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI)…
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product…
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
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…
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…
AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination…
The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased…
Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor and sensor box is…
Exposed to freezing temperatures due to refrigerated truck malfunctions
Exposed to freezing temperatures due to refrigerated truck malfunctions
Exposed to freezing temperatures due to refrigerated truck malfunctions
Exposed to freezing temperatures due to refrigerated truck malfunctions
Exposed to freezing temperatures due to refrigerated truck malfunctions
Exposed to freezing temperatures due to refrigerated truck malfunctions
Exposed to freezing temperatures due to refrigerated truck malfunctions
Exposed to freezing temperatures due to refrigerated truck malfunctions
Temperature Abuse: Product exposed to temperature outside specified limits.
Temperature Abuse: Product exposed to temperature outside specified limits.
Temperature Abuse: Product exposed to temperature outside specified limits.
Temperature Abuse: Product exposed to temperature outside specified limits.
This page summarizes recall records in which the official source identifies Fresenius Medical Care Holdings, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
