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Voluntary Correction Announcement for Argyle™ UVC Insertion Trays containing Safety Scalpel N11
08/20/2021

DUBLIN, OHIO – August 20, 2021 — Cardinal Health (NYSE: CAH) issued a voluntary Medical Device correction notice on June 16, 2021 for Argyle™ UVC Insertion Tray containing Safety Scalpel N11.

The Argyle UVC Insertion Tray is intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonates. The correction applies to all units that were manufactured between August 13, 2019 and March 20, 2021 and distributed between August 13, 2019 and May 21, 2021 to hospitals and wholesalers/distributors nationwide.

SKU

Description

43201

Argyle™ UVC Insertion Tray

We issued this voluntary correction to make users aware of the full Instructions For Use (IFU) for the Safety Scalpel N11, and, in particular, its permanent locking feature. Although the scalpel is functioning as intended, there is a potential risk for procedural delay due to unintentional permanent locking of the scalpel. In the case of a high-risk neonate population, this potential delay could result in death. We received two reports of death in which the Safety Scalpel within the UVC kit was unintentionally locked permanently during the surgical procedure, rendering the clinician unable to unlock for use during emergent UVC placement. The causes of the deaths have not been established to have been the result of the permanently closed (and locked) scalpel.

Customers and distributors who received recalled products began receiving notification on June 16, 2021. Distributors were asked to notify all customers to whom they may have distributed/forwarded affected product.

Our top priority is the safety of patients, our customers and their healthcare workers. We take any product concerns very seriously and are committed to helping ensure quality products for our customers and the patients they serve.

About Cardinal Health
Cardinal Health is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for health care facilities. With 50 years in business, operations in more than 35 countries and approximately 44,000 employees globally, Cardinal Health is essential to care. Information about Cardinal Health is available at cardinalhealth.com.

Contacts
Media: Andrew Stern, andrew.stern@cardinalhealth.com and (614) 339-4678

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