All Recalls

CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.

cGMP deviations and lack of assurance of sterility.

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

Presence of Particulate Matter

Presence of Particulate Matter: Glass particles were found in pellet vials.

cGMP deviations and lack of assurance of sterility.

Presence of Particulate Matter: Glass particles were found in pellet vials.

Lack of Assurance of Sterility

cGMP deviations and lack of assurance of sterility.

Presence of Particulate Matter: Glass particles were found in pellet vials.

cGMP deviations and lack of assurance of sterility.

Presence of Particulate Matter: Glass particles were found in pellet vials.

cGMP deviations and lack of assurance of sterility.

Presence of Particulate Matter: Glass particles were found in pellet vials.

Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.

Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May reboot after intermittent connection with Smart Mount, 4) 12-lead ECG measurements with Louvain algorithm and software before vx.36 could produce inaccurate rhythm/morphology statements.

Potential for exoskeleton to lose lateral balance and cause patient to fall.

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.