Argyle UVC Insertion Tray Recall: Missing Scalpel Instructions Linked To Two Infant Deaths

Federal health officials have announced a Class I recall impacting certain Cardinal Health scalpels, following at least two reports that the devices’ permanent locking feature accidentally engaged while performing catheter implants, resulting in treatment delays that may be responsible for the deaths of at least infants.

The Argyle UVC Insertion Tray Class I recall was announced by the U.S. Food and Drug Administration (FDA) on August 20, due to a risk that the locking feature on Safety Scalpel N11 devices may be unintentionally engaged during emergency catheter implants for critically ill newborns.

Approximately 7,197 Safety Scalpel N11 that were sold as part of the Argyle UVC Insertion Tray are included in the recall. The sterilized surgical kit is used to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of infants.

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According to the recall notice, the scalpels contain a permanent locking feature that will not allow a clinician to unlock the scalpel once they have closed the safety shield and pushed it forward into a locked position.

The recall warns that in the event of the permanent locking feature being unintentionally engaged, physicians could be delayed or unable to perform emergency umbilical vein catheter placement, which poses a safety risk to the patient that could result in delayed treatment, which could lead to serious injury or death.

The FDA announced there have been a total of 10 incidents reported in which the scalpel became inoperable due to the permanent locking feature. Two of the incidents have been linked to infant deaths because the clinician was unable to unlock the device during an emergency UVC placement.

On June 16, 2021, Cardinal Health sent all affected customers an Urgent Medical Device Correction letter, instructing them to review the new Instructions For Use (IFU) for the Safety Scalpel N11 that was included with the letter, and to post a copy of the new IFU where the products are stored.

The recalled Argyle UVC Insertion Tray containing Safety Scalpel N11 were manufactured by Cardinal Health from August 13, 32019 to March 20, 2021, and distributed throughout the U.S. from August 13, 2019 to May 21, 2021. The Insertion Trays are marked with SKU number 43201 and the Safety Scalpel N11 contain vendor part number 73-1811.

Since the manufacturer’s notice, the FDA has designated the recall with a Class I status, indicating it is the most serious of its kind, and that the use of the product may result in serious or potentially life threatening consequences, including death.

Customers are being encouraged to contact the Cardinal Health Customer Service group at 888-444-5440 with any questions about this recall or to arrange a product return.

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