95,114 total recalls in our database
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage to the sterile packaging during shipping. The damage can result in tears to the packaging and has the potential to cause a breach in sterility of the supplied stopcocks.
Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). With manual procedure, no result will be reported as the control will be out of specifications.
Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw.
Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve when desired. This Field Correction reinforces the Directions for Use (DFU) and gives further guidance on correct use of the hemostasis valve to avoid cross-threading and to securely seal the valve, minimizing potential for undesired blood leakage.
SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mechanism may fail and cause the drive mechanism to stop pumping; resulting in the loss of life-sustaining function.