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Discoloration; discolored solution from cracked vials
Lack of Assurance of Sterility
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).
Ultrasound transducer devices were refurbished beyond their useful life.
Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in vivo recalibration, affected probes may experience inaccuracy in other measured parameters, including pCO2, pO2, pH, Potassium and calculated parameters, including BE, Bicarbonate, Arterial Oxygen Saturation, Delivered Oxygen, Area Under of the Curve of Delivered Oxygen, Oxygen Consumption, and Oxygen Extraction Ratio, which utilize temperature as an input. Inaccurate data may lead to inappropriate user response.
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Pseudomonas in Mineral Water. The firm was notified by their distributor that product placed on hold was released and shipped to customers.
Foreign Material (metal)
Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.
Potential to be contaminated with Listeria monocytogenes
undeclared pecans
Products held under insanitary conditions
Potential contamination with Salmonella.
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.