All Recalls

May be contaminated with Listeria monocytogenes

May be contaminated with Listeria monocytogenes

Lack of sterility assurance

CGMP Deviations: Does not meet monograph for denaturant.

CGMP Deviations: Does not meet monograph for denaturant.

Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine.

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

Handheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into the monitor resulting in loss of functionality.

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode. In some locations in the guide, it states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, allowing the patient to end therapy or proceed to their last fill.

Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."