Cardinal Health lands back-to-back FDA Class I recalls for catheter kits, prefilled syringes

Cardinal Health is facing two back-to-back product recalls, each of which was characterized this month as Class I, the FDA’s most serious classification, indicating a heightened risk of serious injury or death.

The first Cardinal has labeled a “voluntary correction,” for its Argyle UVC Insertion Tray and included Safety Scalpel N11. The tray is used to organize tools and equipment needed for umbilical venous catheter procedures, where a catheter is inserted into a critically ill newborn’s umbilical artery.

The kit's scalpel includes a safety shield to cover the blade while it’s not in use. The shield features a mechanism that can lock permanently if the shield is closed and pushed forward into the locked position, rendering it useless.

According to the FDA recall notice, the tray’s instructions for use fail to describe this permanent locking feature, so physicians who are unaware of it may accidentally lock the scalpel and then be forced to waste precious time locating a replacement scalpel.

Two patient deaths have been linked to instances in which clinicians were unable to unlock the Safety Scalpel N11 during emergency UVC insertions. Another 10 complaints have been registered regarding the locking issue, but no other injuries have been reported.

The recall, which was initiated by Cardinal Health in mid-June, comprises nearly 7,200 insertion trays containing the scalpel. The affected products were distributed between August 2019 and May of this year.

To rectify the issue, Cardinal has issued updated user instructions for the insertion kit and scalpel to all affected customers. The company asked that those instructions be shared with all personnel who may be involved in procedures using the Argyle tray and that the instructions be posted wherever the trays are stored.

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Cardinal’s second Class I recall was sparked by a potential issue with its line of Monoject Flush Prefilled Saline Syringes, which are 12-milliliter syringes that come prefilled with varying amounts of saline solution to flush out intravenous tubing systems and intravascular access devices.

A flaw in the mechanism of some of these syringes can cause the plunger to pull back after excess air in the syringe has been expelled, potentially bringing air back into the syringe. If that air is injected into a patient’s blood vessels, it could cause an air embolism, in which an air bubble blocks a vein or artery and can lead to heart attack, stroke or respiratory failure.

No injuries have been linked to the issue so far, but Cardinal has received 37 reports of the syringe plungers pulling back.

In this case, the company is calling for all affected devices to be immediately returned. The recall includes Monoject syringes containing three-, five- and 10-milliliter amounts of saline solution that were distributed between July 2019 and July 2021.

Cardinal’s three-milliliter syringe containing 2.5 milliliters of saline solution isn’t affected by the recall and will continue being sold until its inventory is depleted, but the company noted that the recall will nonetheless likely cause a shortage of prefilled saline syringes—thanks to additional constraints caused by “the limited number of alternative prefilled saline syringe options, combined with ongoing supply, transportation and labor challenges,” according to Cardinal’s recall notice.

“We are actively working to address the disruption and support customers’ needs with locating alternative supply and we suggest that clinicians work with their facility to determine alternative fill methods,” Cardinal said.