(Reuters) – The U.S. Food and Drug Administration on Friday classified the recall of some of Cardinal Health Inc’s devices, which are used to insert umbilical vein catheters in infants, as the most serious type of recall after two reports of death.
Class I recall is the strictest form of recall issued by the FDA, where the usage of faulty devices may cause serious injury or even death.
The company had initiated a recall of some of its Argyle UVC Insertion Trays in June due to missing instructions on how to unlock the safety scalpel N11.
The N11 scalpel has a permanent locking feature, but there could be a delay in the procedure if the clinician is not aware how to unlock the scalpel.
The FDA said the two deaths occurred when an N11 scalpel within the UVC kit got permanently locked during an emergency procedure.
The agency said the recall affects about 7197 devices, which were distributed between August 13, 2019 and May 21, 2021 in the United States, and that it had so far received 10 complaints related to the recalled products.
(Reporting by Mrinalika Roy in Bengaluru, Editing by Sherry Jacob-Phillips)