FDA classifies recall of Cardinal Health's catheter devices as most
serious
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[August 21, 2021]
(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.
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 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.
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 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)
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