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Cardinal Health issued a recall of an insertion tray used during emergency intravenous catheter placement for critically ill newborns after its scalpel was implicated in the death of two infants, on Friday.

Notably, the agency classified this as a class I recall, the most serious type, which is reserved for cases where use of a device could cause harm or death.

The Argyle Umbilical Venous Catheter (UVC) Insertion Tray was officially recalled for lacking "specific instructions" for use of Safety Scalpel N11. The FDA noted that the scalpel has a "permanent locking feature" that does not allow the clinician to unlock the scalpel again once the safety shield is closed and pushed into a locked position. Because clinicians are not aware of this feature, there may be a delay for patients who require emergency umbilical vein catheter placement.

The FDA noted there were 10 complaints about the scalpel, and two reports of death after the scalpel was permanently locked, unintentionally, during surgery. In total, 7,197 devices were recalled, with manufacturing dates from Aug. 13, 2019 to March 20, 2021, and distribution dates from Aug. 13, 2019 to May 21, 2021.

The agency noted that Cardinal Health sent an Urgent Medical Device Correction letter this June, which included the instructions for use for the scalpel, with the directive to review the instructions, share them with any personnel who used the insertion tray and notify any customers who may have distributed the affected product.

FDA on Friday also announced involving Cardinal Health's products, affecting roughly 267 million of its saline syringes (MonojectTM Flush Prefilled Saline Syringes, 0.9% sodium chloride). The syringes were manufactured from July 2019-June 2021 and distributed from July 2019-July 2021.

"The products have been found to reintroduce air into the syringe after the air has been expelled," the agency noted, which "could result in injection of air into blood vessels and create the potential for air embolism, which can cause serious adverse health outcomes or death."

To date, 37 reports of the plunger pulling back have been reported to the company, though no injuries have been recorded.

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