PharMedium Services Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7.5 mMol in 100 recall — FDA D-0992-2017
Lack of Assurance of Sterility; media fill failure at manufacturer
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Lack of Assurance of Sterility; media fill failure at manufacturer
Lack of Assurance of Sterility; media fill failure at manufacturer
Lack of Assurance of Sterility; media fill failure at manufacturer
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Lack of Assurance of Sterility; media fill failure at manufacturer
Lack of Assurance of Sterility; media fill failure at manufacturer
Lack of Assurance of Sterility; media fill failure at manufacturer
Lack of Assurance of Sterility; media fill failure at manufacturer
Lack of Assurance of Sterility; media fill failure at manufacturer
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Lack of Assurance of Sterility; media fill failure at manufacturer
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Lack of Assurance of Sterility; media fill failure at manufacturer
Software- scheduled A-QC analysis could initiate prior to a patient result being released by the operator and result in the pending patient result being overwritten with the A-QC test…
Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood flow.
The Reusable Oscor ATAR extension cables could separate from the connector during use.
A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the…
The connection between the Female Luer and the NanoClave manifold has the potential for developing a leak.
Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood flow.
When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the…
Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm.
The connection between the Female Luer and the NanoClave manifold has the potential for developing a leak.
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