The FDA put its highest-risk category on Johnson & Johnson (NYSE:JNJ) subsidiary Animas Corp.’s insulin pump recall over concerns that the devices may cause patient harm or even death.
Certain pumps were recalled over concerns that a "component" issue could trigger a false alarm or a sudden warning requiring that the patient rewind, load and prime the device.
If the patient fails to follow the instructions, or fails to disconnect the infusion set from the body beforehand, the device may deliver an unintended dose of insulin that may place patients at harm, according to the FDA notice.
The recall includes Animas 2020 infusion insulin pumps manufactured from March 1, 2012, to November 30, 2012. The same pumps were the center of a U.K. warning over a software issue that will make render the devices defunct on the stroke of midnight on December 31, 2015.
Animas asked that customers with the affected products return the pumps for a free replacement.