Cardinal Health recalled Aug. 20 a supply kit used during a procedure for critically ill newborns after finding it doesn't include specific instructions for the scalpel, which has a permanent locking feature. The scalpel has been linked to two patient deaths, but the causes of death haven't been established as being the result of the device, Cardinal Health said.
The Argyle UVC insertion tray is used for emergency umbilical vein catheter placement procedures in newborns. The safety scalpel included in the kit has a permanent locking feature that doesn't allow the clinician to unlock it once they have closed the safety shield and pushed it forward into a locked position.
If a clinician is unaware of the permanent locking feature, there could be a delay in the procedure as they have to obtain a new scalpel.
There have been 10 complaints reported about the issue, including two reports of death in which the scalpel locked permanently and the clinician was unable to unlock it during an emergency procedure, according to the FDA.
Cardinal Health said in a statement: "The causes of deaths have not been established to have been the result of the permanently closed (and locked) scalpel."
Cardinal Health sent all affected customers letters June 16 warning them of the issue and providing instructions for the safety scalpel.
All of the recalled supplies were distributed to hospitals nationwide between Aug. 13, 2019, and May 21, 2021.
"Our top priority is the safety of patients, our customers and their healthcare workers. We take any product concerns very seriously and are committed to helping ensure quality products for our customers and the patients they serve," Cardinal Health said in the statement. The company declined to provide further comment to Becker's.