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Failed dissolution specifications: lower than specifications
Potential foreign material (wood-like material)
Shelf stable Teriyaki sauce showing signs of micro growth (bubbling) and swelling containers.
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Contains undeclared egg
Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.
The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.
CGMP Deviations
Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow Wrench or No External Power alarms. If MPU losses power, System Controller can support the pump up to 15 minutes, and if not switched to rechargeable batteries, pump may lose power.
Recall was initiated due to potential failure of the seal and potential to be contaminated with Clostridium botulinum.
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.